FDA Adverse Event
Malfunction
Summary report: N
DEPUY DRILL BIT
MDR report key: 1832187
·
Received September 7, 2010
Report
- Report Number
- MW5017338
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING A RIGHT TOTAL HIP REPLACEMENT, A DRILL BIT FROM A HIP REVISION SET WAS USED TO DRILL DOWN INTO THE ISTHMUS. APPROXIMATELY 3 CM OF THE END OF THE DRILL BIT BROKE OFF, THIS WAS GRASPED WITH SCHLESINGER RONGEUR AND REMOVED COMPLETELY. THE OPERATIVE PROCEDURE CONTINUED WITHOUT COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY DRILL BIT | DEPUY DRILL BIT | HTW | DEPUY ORTHOPAEDICS | 2447-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |