FDA Adverse Event
Injury
Summary report: N
BIOMET
MDR report key: 2560376
·
Received May 6, 2010
Report
- Report Number
- 2560376
- Event Type
- Injury
- Date Received
- May 6, 2010
- Date of Event
- May 4, 2010
- Report Date
- May 4, 2010
- Manufacturer
- BIOMET
- Product Code
- HTW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UPON REMOVING PIN, THE SPRING WAS DESTROYED AND TIP BROKE OFF IN PT'S BONE. THIS WAS NOTED ON PT'S POST-OP X-RAY APPROX 18 MM REMAINS IN PT. SCREW WAS REMOVED BY POWER DRILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | DRILL | HTW | BIOMET | 422401 | 866170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |