FDA Adverse Event
Injury
Summary report: N
ZZIMMER PIRIFORMAIS FOSSA FEMORAL NAIL
MDR report key: 4092464
·
Received September 4, 2014
Report
- Report Number
- 1822565-2014-01076
- Event Type
- Injury
- Date Received
- September 4, 2014
- Date of Event
- August 7, 2014
- Report Date
- August 8, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE SIZE OF NAIL THE SURGEON NEEDED WAS UNAVAILABLE. AS A RESULT, THE SURGEON FELT FORCED TO REAM AN ADDITIONAL 1MM OF BONE FROM THE PT'S FEMUR TO ACCOMMODATE A LARGER NAIL. ADDITIONALLY, THE SURGEON FEELS THE ADDITIONAL REAMING MAY HAVE CONTRIBUTED TO THE PT'S CURRENT PULMONARY DISTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542164 | ZZIMMER PIRIFORMAIS FOSSA FEMORAL NAIL | HSB | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | UNK ZIMMER NAIL, CAT #UNK, LOT #UNK |