FDA Adverse Event
Other
Summary report: N
BIOMET
MDR report key: 306488
·
Received November 27, 2000
Report
- Report Number
- 306488
- Event Type
- Other
- Date Received
- November 27, 2000
- Date of Event
- October 21, 2000
- Report Date
- November 22, 2000
- Manufacturer
- BIOMET INC
- Product Code
- HTW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DRILL BECAME LODGED IN FEMORAL CANAL DURING PROCEDURE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DRILL BIT. DRILL BIT HAD TO BE CUT AND THE TIP WITH A SMALL PORTION OF THE DRILL SHAFT REMAINED IN THE FEMORAL CANAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | 9.5 MM DISK DRILL | HTW | BIOMET INC | * | 788690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |