1/8" HEX DRIVE
Report
- Report Number
- 0002249697-2013-01474
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K123166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE NORMAL WEAR AND TEAR. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.
IT WAS REPORTED THAT THE HEX SCREWDRIVER IS WORN OUT FROM OVER USAGE. THE TIP IS STRIPPED AND WILL NOT ENGAGE THE SCREWS WELL ENOUGH TO TIGHTEN. WE OPENED ANOTHER MISC TRAY AND USED THE HEX SCREWDRIVER OUT OF THAT PAN.
IT WAS REPORTED THAT THE HEX SCREWDRIVER IS WORN OUT FROM OVER USAGE. THE TIP IS STRIPPED AND WILL NOT ENGAGE THE SCREWS WELL ENOUGH TO TIGHTEN. WE OPENED ANOTHER MISC TRAY AND USED THE HEX SCREWDRIVER OUT OF THAT PAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183619 | 1/8" HEX DRIVE | INSTRUMENT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | SC1902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |