FDA Adverse Event
Malfunction
Summary report: N
GUIDE PIN
MDR report key: 19941141
·
Received August 7, 2024
Report
- Report Number
- MW5158182
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- July 31, 2024
- Report Date
- August 2, 2024
- Manufacturer
- ZIMMER BIOMET/ZIMMER, INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ZIMMER PIN BROKE OFF WHILE DRILLING DURING THA (TOTAL HIP ARTHROPLASTY), BROKEN PIECE REMOVED FROM PATIENT AND TAKEN OFF OF STERILE FIELD. NO HARM TO PATIENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1636149 | GUIDE PIN | SCREW, FIXATION, BONE | HWC | ZIMMER BIOMET/ZIMMER, INC. | 290.20.280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |