FDA Adverse Event
Malfunction
Summary report: N
ZIMMER BIOMET TREPHINE
MDR report key: 20757813
·
Received November 21, 2024
Report
- Report Number
- MW5162774
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- August 30, 2024
- Report Date
- November 19, 2024
- Manufacturer
- ZIMMER BIOMET
- Product Code
- HWK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE TIP OF A ZIMMER TREPHINE BROKE WHILE THE SURGEON WAS ATTEMPTING TO REMOVE A SCREW DURING A LOWER EXTREMITY REMOVAL OF A BONE PLATE AND SCREW PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2221490 | ZIMMER BIOMET TREPHINE | TREPHINE | HWK | ZIMMER BIOMET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male |