FDA Adverse Event
Malfunction
Summary report: N
NAIL HOLDING SCREW
MDR report key: 2430706
·
Received January 6, 2012
Report
- Report Number
- 9610622-2012-00001
- Event Type
- Malfunction
- Date Received
- January 6, 2012
- Date of Event
- December 7, 2011
- Report Date
- December 7, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ASSOCIATED DEVICE: WRENCH 8/10MM; CATALOG # 1806-0130, LOT # K830498. AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER. EVALUATION REVEALED THAT THE ROOT CAUSE COULD NOT BE CLARIFIED BECAUSE THE PRODUCTS WERE NOT AVAILABLE FOR INVESTIGATION. THE NAIL HOLDING SCREWS MANUFACTURING HISTORY INDICATES THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE OPEN END WRENCH 8/10MM DIDN'T FIT THE SCN NAIL HOLDING SCREW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAIL HOLDING SCREW | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K589437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |