FDA Adverse Event
Malfunction
Summary report: N
ZIMMER NATURAL NAIL 6.0MM CANCELLOUS SCREW
MDR report key: 2150558
·
Received June 22, 2011
Report
- Report Number
- 1822565-2011-01483
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 21, 2011
- Report Date
- May 26, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SCREW THREADS AND HEX HEAD STRIPPED. PORTIONS OF THE THREADS WERE FOUND TO HAVE SEPARATED FROM THE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER NATURAL NAIL 6.0MM CANCELLOUS SCREW | HSB | ZIMMER, INC. | 61180694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |