FDA Adverse Event
Malfunction
Summary report: N
BIOMET ORTHOPEDICS
MDR report key: 1037635
·
Received May 2, 2008
Report
- Report Number
- MW5006553
- Event Type
- Malfunction
- Date Received
- May 2, 2008
- Date of Event
- March 27, 2008
- Report Date
- April 28, 2008
- Manufacturer
- BIOMET ORTHOPEDICS, INC
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING TOTAL JOINT PROCEDURE DRILL BIT USED IN POWER DRILL BROKE INTO 2 PARTS. SURGEON EXAMINED THE REMAINING PORTION OF THE DRILL BIT, AND THEN THE BIT WAS GIVEN TO THE DIRECTOR OF SURGICAL SERVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET ORTHOPEDICS | BIOMET DRILL BIT | HTW | BIOMET ORTHOPEDICS, INC | HIP JOINT DRILL BIT | NOT KNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |