FDA Adverse Event
Malfunction
Summary report: N
FEMORAL NAIL, COMPRESSION 10X340MM
MDR report key: 2456151
·
Received January 26, 2012
Report
- Report Number
- 9610622-2012-00055
- Event Type
- Malfunction
- Date Received
- January 26, 2012
- Date of Event
- January 10, 2012
- Report Date
- January 11, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K021026
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ACCORDING TO OUR WAREHOUSE COORDINATOR, DURING ONE S2 NAIL SURGERY, THE TEAM TRIED TO IMPLANT A (B)(4) (LOT K642528) NAIL, BUT AFTER HAVING SOME PROBLEMS, THEY REALIZED THAT THE NAIL HAD A DIFFERENT BENDING OR CURVE. AFTER REALIZING THIS, THE TEAM DECIDED TO USE ANOTHER NAIL. AT THE END, THEY IMPLANT A (B)(4) NAIL. THE NAIL WAS COMPARED TO ANOTHER S2 NAIL. THE PROXIMAL LOCKING HOLES HAD A DIFFERENT POSITION WHEN ALIGNING THIS NAIL WITH THE OTHER NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, COMPRESSION 10X340MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K642528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |