FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT
MDR report key: 17372053
·
Received July 19, 2023
Report
- Report Number
- MW5119779
- Event Type
- Malfunction
- Date Received
- July 19, 2023
- Report Date
- July 14, 2023
- Manufacturer
- ZIMMER BIOMET / ZIMMER, INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HAD A POSTERIOR APPROACH RIGHT TOTAL HIP REPLACEMENT. WHILE PERFORMING THE PROCEDURE, THE DRILL BIT BY ZIMMER BIOMET THAT WAS USED TO DRILL THE ACETABULUM BROKE INTO 2 PIECES. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT. THIS INCIDENT HAS ALREADY BEEN SHARED WITH THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771857 | DRILL BIT | BIT, DRILL | HTW | ZIMMER BIOMET / ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |