FDA Adverse Event
Malfunction
Summary report: N
BIOMET
MDR report key: 564245
·
Received December 10, 2004
Report
- Report Number
- MW1034261
- Event Type
- Malfunction
- Date Received
- December 10, 2004
- Date of Event
- November 16, 2004
- Report Date
- December 3, 2004
- Manufacturer
- BIOMET
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING TOTAL KNEE REPLACEMENT SURGERY THE PATELLA CLAMP INSTRUMENT WAS BEING USED TO HOLD THE PATELLA IMPLANT IN PLACE. THE SPRING PIECE IN THE HANDLE BROKE AND FLEW ONTO THE FLOOR. UPON INSPECTION, FOUND TWO SCREWS MISSING FROM THE BROKEN PIECE, UNABLE TO LOCATE MISSING SCREWS. NO KNOWN HARM TO PT.
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 3/7/05: THIS EVENT WAS NOT CONSIDERED BY BIOMET INC. TO BE MEDWATCH REPORTABLE AS THERE WAS NO PT IMPACT. REFERENCE SECTION B5 AND B6 ON USER FACILITY'S MEDWATCH REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | PATELLA CLAMP | LXH | BIOMET | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |