FDA Adverse Event
Malfunction
Summary report: N
END CAP, STANDARD 8 MM
MDR report key: 2167005
·
Received June 10, 2011
Report
- Report Number
- 9610622-2011-00247
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 24, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K003018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CHAIRMAN FOR THE DEPARTMENT OF ORTHOPAEDICS REPORTED TO SR DIRECTOR OF R&D AT STRYKER OSTEOSYNTHESIS, (B)(6), THAT IT IS OBSERVED, IN SEVERAL CASES THAT THE END CAPS DID NOT FIT ONTO THE NAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | END CAP, STANDARD 8 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |