P09. SOW Stryker Universal Facial Fixation Set.pdf

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6515--Stryker Universal Fixation Set
Solicitation number
36C26326Q0854
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This is a Statement of Work (SOW) for the purchase of one Stryker Universal Facial Fixation Set for the Omaha Veterans Affairs Medical Center (VAMC) Surgery Department.

The Stryker Universal Facial Fixation Set is a collection of medical instruments and tools designed for fixation and stabilization of facial bones during surgical procedures, including facial trauma repair, orthognathic surgery, reconstructive surgery, and craniofacial surgery. The set comprises numerous components including plates and screws of various sizes, instrumentation for screw and plate placement such as drills and screwdrivers, benders and cutters, orbital floor plates, dynamic mesh, bone screws in multiple configurations, modules with lids for organization, handle/drivers, forceps, plate benders, and trays for specialized procedures. The vendor must be an authorized Stryker distributor and must provide a letter of authorization from the original equipment manufacturer (OEM). Delivery is to the Omaha VAMC Surgery Department at 4101 Woolworth Avenue, Omaha, Nebraska 68105. The vendor must provide user manuals describing proper use, care, and cleaning, as well as a service manual in electronic format that includes theory of operation, maintenance requirements, repair information, schematics, part lists, and troubleshooting information for the VA Biomedical Engineering Department. Instruments must be new (not used or refurbished), have a manufacture date no greater than one year before the purchase order date, and include the latest manufacturer's software and hardware updates.

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Statement of Work

Stryker Universal Facial Fixation Set Brand Name Only

Subject:

Purchase 1 set of a Stryker Universal Facial Fixation Set for the Omaha Surgery Department.

Site:

Omaha VAMC Surgery Department

Background:

We need a new facial fixation set for oral surgery and ENT. Our current Stryker Facial Fixation pan is now obsolete, and we are no longer able to order new implants/supplies for the pan when something gets used. Dr. Untrauer has been sending out Jaw alignment cases that he hopefully could keep in house if we had this set. Authorized Distributors only. Vendor must be able to provide letter of authorization from the OEM.

Objective:

Purchase 1 set of a Stryker Universal Facial Fixation set.

General:

The Stryker Universal Facial Fixation set is a collection of medical instruments and tools designed for the fixation and stabilization of facial bones during surgical procedures. This set is often used by maxillofacial surgeons for procedures such as:

Facial Trauma Repair: Fixation of fractures in the facial skeleton, including the mandible, maxilla, zygomatic bones, and orbital fractures.

Orthognathic Surgery: Corrective surgery for misaligned jaws, including Le Fort I, II, and III osteotomies.

Reconstructive Surgery: Restoration of facial form and function following trauma, tumor resection, or congenital deformities.

Craniofacial Surgery: Complex reconstructive procedures involving the cranial bones and facial skeleton.

Components typically found in the Stryker Universal Facial Fixation set may include:

Plates and screws of various sizes and shapes for rigid fixation.

Instrumentation for the placement of screws and plates, such as screwdrivers, drills, and drills bits.

Benders and cutters for customizing plates to fit the specific anatomy of the patient.

These sets allow for a customizable and flexible approach to managing different types of facial fractures and surgical requirements.

The vendor will provide user manuals that describe proper use, care and cleaning for users of equipment.

The vendor shall provide a service manual that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

Date of manufacture must not be greater than 1 year before the purchase order date. The instruments must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed.

Details:

Set will be comprised of the following:

Stryker Universal Facial Fixation Set

Set components, include:

2 EA 5504218 PLT/18 HOLE STRT UP MALLEABLE

2 EA 5504424 PLT/24 HOLE STRT UP MALL CNDSD

2 EA 5504233 3D PLATE/6X2 HL UPPER FC MALBL

2 EA 5504231 3D PLATE/2X2 HL UPFACE MALLBL

2 EA 5504250 PLT/10 HOLE CURV UP MALL CNDSD

2 EA 5504240 PLT/7 HOLE DOUBLE Y UPFC MLBL

2 EA 5506208 PLT/1.2MM UPPER FACE 8 HOLE

2 EA 5506224 PLT/24 HOLE STRT UPPERFACE

2 EA 5506250 PLT/10 HOLE CURVED UPPERFACE

2 EA 5506254 PLT/4 HOLE ORBITAL UPPERFACE

2 EA 5506240 PLT/7 HOLE DOUBLE Y UPPERFACE

2 EA 5506270 PLT/7 HOLE T UPPERFACE

2 EA 5506260 PLT/8 HOLE L 90D LFT UPPERFC

2 EA 5506261 PLT/8 HOLE L 90D RGHT UPPFC

1 EA 5404005 3D ORBITAL FLR PLT, RIGHT, LG

1 EA 5404004 3D ORBITAL FLR PLT, RIGHT,SM

1 EA 5404007 3D ORBITAL FLR PLT, LEFT, LG

1 EA 5404006 3D ORBITAL FLR PLT, LEFT, SM

1 EA 5690624 1.2MM DYNAMIC MESH, STD, MED

1 EA 5690324 1.2MM DYNAMIC MESH,MALL, MED

2 EA 6009504 TW DRL/.9X46MM DRL,4MMSTOP,END

2 EA 6010506 TW DRL/1X50MM DRL,6MMSTOP,END

2 EA 6010512 TW DRL/1X54MMDRL12MM STOP,END

10 PK 5614005 BONESCREW,ER,AXS,ST,1.4X5MM,5P

10 PK 5614003 BONESCREW,ER,AXS,ST,1.4X3MM,5P

40 PK 5612904 BONESCREW,AXS,SD,1.2X4MM,5P

60 PK 5612903 BONESCREW,AXS,SD,1.2X3MM,5P

5 PK 5612012 BONESCREW,AXS,ST,1.2X12MM,5P

5 PK 5612010 BONESCREW,AXS,ST,1.2X10MM,5P

5 PK 5612008 BONESCREW,AXS,ST,1.2X8MM,5P

10 PK 5612006 BONESCREW,AXS,ST,1.2X6MM,5P

15 PK 5612005 BONESCREW,AXS,ST,1.2X5MM,5P

35 PK 5612004 BONESCREW,AXS,ST,1.2X4MM,5P

25 PK 5612003 BONESCREW,AXS,ST,1.2X3MM,5P

1 EA 2912900 1.2 UF PLT/SCR MODULE W/LID

1 EA 2912901 1.2 ORBIT PL/MESH MODULE W/LID

40 PK 5617904 BONESCREW,AXS,SD,1.7X4MM,5P

30 PK 5617004 BONESCREW,AXS,ST,1.7X4MM,5P

5 PK 5617010 BONESCREW,AXS,ST,1.7X10MM,5P

2 EA 6220285 HANDLE/DRIVER/TAP 1.5/2.0

1 EA 6218110 FORCEP/UNIVERSAL PLATE

1 EA 6212176 PLATE BENDER/UPERFC/MIDFACE LF

1 EA 6212175 PLATE BENDER/UPERFC/MIDFACE RT

1 EA 6212173 BENDER/UPPERFC/MIDFACE 3 PRNG

1 EA 6232440 BONE REPOSITIONING PIN/3.2MM

2 EA 6020012 TW DRL/2X62MM WL 13MM REP PIN

1 EA 2913901 UPPER/MIDFACE INST TRAY

1 EA 2917901 1.7 MF PLT MODULE W/LID

2 EA 6013512 TW DRL/1.4X54MM/12MMSTOP EN

2 EA 6014008 TW DRL/F. 8MM SCREWS, 1.4X54MM

2 EA 6013506 TW DRL/1.35X50MM/WL/6MM/STRYKER

2 EA 6013505 TW DRL/5MM S 1.35X50MM

2 EA 5506767 PLT/6HL/L/12MMADVC 100D RT STD

2 EA 5506766 PLT/6HL/L/12MMADVC 100D LT STD

2 EA 5506765 PLT/6HL/L/8MM ADVC 100D RT STD

2 EA 5506764 PLT/6HL/L/8MM ADVC 100D LT STD

2 EA 5506763 PLT/5HL/L/5MM ADVC 100D RT STD

2 EA 5506762 PLT/5HL/L/5MM ADVC 100D LT STD

2 EA 5506761 PLT/5HL/L/2MM ADVC 100D RT STD

2 EA 5506760 PLT/5HL/L/2MM ADVC 100D LT STD

2 EA 5505164 PLT/7 HOLE DOUBLE Y MDFC

2 EA 5505152 PLT/5 HOLE Y W/8MM BAR MDFC

2 EA 5505151 PLT/5 HOLE Y W/4MM BAR MDFC

2 EA 5506771 PLT/5 HOLE T MIDFACE

2 EA 5506750 PLT/10 HOLE CURVED MIDFACE

2 EA 5505188 PLT/HOLE ORBITAL RIM MIDFACE

2 EA 5506754 PLT/4 HOLE CRVD W/BAR MDFC

2 EA 5506733 3D PLATE/2X6 HL MIDFACE

2 EA 5506731 3D PLATE/2X2 HL MIDFACE

2 EA 5506724 PLT/24 HOLE STRAIGHT MIDFACE

2 EA 5506708 PLT/8 HOLE MIDFACE

2 EA 5506704 PLT/4 HOLE STRT W/BAR MDFC

2 EA 5504766 PLT/6 HOLE L 12MMADVMT 100D LT

2 EA 5504767 PLT/6 HOLE L 12MMADVMT 100D RT

2 EA 5504764 PLT/6 HOLE L 8MM ADVMT 100D LT

2 EA 5504765 PLT/6 HOLE L 8MM ADVMT 100D RT

2 EA 5504762 PLT/5 HOLE L 5MM ADVMT 100D LT

2 EA 5504763 PLT/5 HOLE L 5MM ADVMT 100D RT

2 EA 5504760 PLT/5 HOLE L 2MM ADVMT 100D LT

2 EA 5504761 PLT/5 HOLE L 2MM ADVMT 100D RT

2 EA 5503733 3D PLATE/2X6 HL MDFC MALLEABLE

2 EA 5503731 3D PLATE/2X2 HL MDFC MALLEABLE

2 EA 5504720 PLT/20 HL STRT MDFC MALLEABLE

2 EA 5504724 PLT/24 HL STRT MDFC MLBL CNDS

10 PK 5619005 BONESCRW,EMG,AXS,ST,1.9X5MM,5P

10 PK 5619003 BONESCRW,EMG,AXS,ST,1.9X3MM,5P

10 PK 5617906 BONESCREW,AXS,SD,1.7X6MM,5P

10 PK 5617905 BONESCREW,AXS,SD,1.7X5MM,5P

40 PK 5617903 BONESCREW,AXS,SD,1.7X3MM,5P

5 PK 5617012 BONESCREW,AXS,ST,1.7X12MM,5P

10 PK 5617008 BONESCREW,AXS,ST,1.7X8MM,5P

10 PK 5617006 BONESCREW,AXS,ST,1.7X6MM,5P

25 PK 5617005 BONESCREW,AXS,ST,1.7X5MM,5P

15 PK 5617003 BONESCREW,AXS,ST,1.7X3MM,5P

2 EA 6212174 AXS BLADE, STD, 1.2/1.7MM

1 EA 2917900 1.7 MF PLT/SCR MODULE W/LID

1 EA 2917902 1.7 MF MALLEABLE PLATE INLAY

5 EA 5627514 LOCKSCREW,EMERG,AXS,ST,2.7X

5 EA 5627510 LOCKSCREW,EMERG,AXS,ST,2.7X

5 EA 5627410 BONESCREW,EMERG,AXS,ST,2.7X

5 EA 5627408 BONESCREW,EMERG,AXS,ST,2.7X

10 EA 5623504 LOCKSCREW,AXS,ST,2.3X4MM,5P

5 EA 5623516 LOCKSCREW,AXS,ST,2.3X16MM,5

10 EA 5623404 BONESCREW,AXS,ST,2.3X4MM,5P

5 EA 5620516 LOCKSCREW,AXS,ST,2.0X16MM,5

5 EA 5620514 LOCKSCREW,AXS,ST,2.0X14MM,5

5 EA 5620416 BONESCREW,AXS,ST,2.0X16MM,5

2 EA 6019620 1.9X110MM DRILL, COLOR MARKS

2 EA 6016620 1.6X110MM DRILL, COLOR MARKS

2 EA 5510515 PLT/16 HL STRT MAN LOCK CONDSD

2 EA 9255506 PLT/4-HOLE PREBENT -LEFT

2 EA 9255505 PLT/4-HOLE PREBENT -RIGHT

1 EA 2923900 2.0/2.3 MAND SCR MODULE W/LID

1 EA 2923902 2.0/2.3 MINI PLT INLAY LARGE

1 EA 2923901 2.0/2.3 PLT MODULE W/LID

1 EA 2913905 TRAY TROCAR SYSTEM

1 EA 2913904 TRAY MANDIBLE FRACTURE INST

1 EA 6400176 FORCEP/PLATE/BONE RIGHT

1 EA 6400175 FORCEP/PLATE/BONE LEFT

2 EA 9219135 DRILL,1.9X115MM,35MM WL, COLOR

2 EA 9216135 DRILL,1.6X115MM,35MM WL,COLOR

1 EA '0108630 FORCEP/BONE REDUCTION

1 EA 6400243 BENDER CUTTER/RIGHT

1 EA 6400242 BENDER CUTTER/LEFT

1 EA 6208430 UNIV MAND DEPTH GUAGE, BLACK

1 EA 6204230 UMAN 2.0/2.3MM DRILL GUIDE,CEN

1 EA 6200442 UMAN VAR CHK RET, W/LT SOURCE

1 EA 6200416 UMAN CAN, FR 6200400,TRAUMA TP

1 EA 6200414 UCHEEK RETRACTOR, W/LT SOURCE

1 EA 6200403 UNIV MAND TROCAR FOR 6200400

1 EA 6200400 UNIV TROCAR HANDLE, NO CANNULA

2 EA 6019526 TW DRL/DRILL 20MM S 1.9X58MM

2 EA 6019135 1.9X115MM DRILL, STRYKER END

2 EA 6016135 1.6X115MM DRILL, STRYKER END

2 EA 6016526 TW DRL/1.6X58MM WKLG 26M

2 EA 6016007 TW DRL/1.6MM 7MM STRYKER

2 EA 6016005 TW DRL/1.6MM 5MM

2 EA 5515536 PLT/ANGLE FRACTURE 6 HOLES 140

2 EA 5515514 PLT/FRACTURE 14 HOLES

2 EA 5515507 PLT/FRACTURE 6 HOLES W. BAR

2 EA 5515506 PLT/FRACTURE 6 HOLES

2 EA 5515505 PLT/FRACTURE 4 HOLES W.BAR

2 EA 5515504 PLT/FRACTURE 4 HOLES

2 EA 5510562 3D PLATE/6X2 HL,CURVED SQUAR

2 EA 5510542 3D PLATE/4X2 HL, SQUARE

2 EA 5510532 3D PLATE/3X2 HL, RECTANGLE

2 EA 5510516 PLT/MINI 16 HOLES

2 EA 5510507 PLT/6 HL STRT W/BAR,MAND, LOCK

2 EA 5510506 PLT/MINI 6 HOLES

2 EA 5510505 PLT/MINI 4 HOLES WITH BAR

2 EA 5510504 PLT/MINI 4 HOLES

2 EA 5510503 PLT/4 HL ST LNG BAR,MAND,LOCK

5 EA 5627512 LOCKSCREW,EMERG,AXS,ST,2.7X

5 EA 5627508 LOCKSCREW,EMERG,AXS,ST,2.7X

5 EA 5627412 BONESCREW,EMERG,AXS,ST,2.7X

5 EA 5627405 BONESCREW,EMERG,AXS,ST,2.7X

5 EA 5623514 LOCKSCREW,AXS,ST,2.3X14MM,5

15 EA 5623512 BONESCREW,AXS,ST,2.3X12MM,5

15 EA 5623510 LOCKSCREW,AXS,ST,2.3X10MM,5

10 EA 5623508 LOCKSCREW,AXS,ST,2.3X8MM,5P

15 EA 5623506 LOCKSCREW,AXS,ST,2.3X6MM,5P

10 EA 5623414 BONESCREW,AXS,ST,2.3X14MM,5

15 EA 5623412 BONESCREW,AXS,ST,2.3X12MM,5

15 EA 5623410 BONESCREW,AXS,ST,2.3X10MM,5

10 EA 5623408 BONESCREW,AXS,ST,2.3X8MM,5P

15 EA 5623406 BONESCREW,AXS,ST,2.3X6MM,5P

10 EA 5620512 LOCKSCREW,AXS,ST,2.0X12MM,5

10 EA 5620510 LOCKSCREW,AXS,ST,2.0X10MM,5

15 EA 5620508 LOCKSCREW,AXS,ST,2.0X8MM,5P

10 EA 5620506 LOCKSCREW,AXS,ST,2.0X6MM,5P

10 EA 5620505 LOCKSCREW,AXS,ST,2.0X5MM,5P

10 EA 5620504 LOCKSCREW,AXS,ST,2.0X4MM,5P

5 EA 5620414 BONESCREW,AXS,ST,2.0X14MM,5

10 EA 5620412 BONESCREW,AXS,ST,2.0X12MM,5

10 EA 5620410 BONESCREW,AXS,ST,2.0X10MM,5

15 EA 5620408 BONESCREW,AXS,ST,2.0X8MM,5P

10 EA 5620406 BONESCREW,AXS,ST,2.0X6MM,5P

10 EA 5620405 BONESCREW,AXS,ST,2.0X5MM,5P

10 EA 5620404 BONESCREW,AXS,ST,2.0X4MM,5P

1 EA '01108115 FORCEP/SELF-RETAINING PLATE

4 EA 6220290 SMARTLOCK RATCHET SCREWDRIVER

2 EA 6220133 AXS SCREWDRIVER BLADE,MMF

4 EA 6220134 AXS SCREWDRIVER BLADE,2.0/2

2 EA 6218330 CUTTER/UPPR/MID FC IN-SITU PLT

1 EA 6200605 SMARTLOCK HMMF PLATE SPACER

1 EA 6200604 SMARTLOCK HMMF PLATE BENDER

1 EA 2923907 2.0 HMMF PLT/SCR MODULE W/LID

1 EA 2913908 TRAY HMMF INSTRUMENTS

16 EA 5620362 MMF SCREW,AXS,SD,2.0X12MM,4

16 EA 5620358 MMF SCREW,AXS,SD,2.0X8MM,4P

2 PK '0103492 LIGATURE WIRE/160MM LENGTH

2 PK '0103490 LIGATURE WIRE/BLUNT 160MM

4 PK 5502951 SMARTLOCK HMMF PLATE, SMALL

4 PK 5502950 SMARTLOCK HMMF PLATE

20 EA 5620998 HMMF LOCKSCREW,AXS,SD,2.0X8

20 EA 5620996 HMMF LOCKSCREW,AXS,SD,2.0X6

Delivery Address:

Omaha VAMC Surgery Department

4101 Woolworth Ave

Omaha, Ne. 68105

File details come from the government source that posted it. Updated .