FDA Adverse Event
Malfunction
Summary report: N
CODMAN HOEN ANGULAR FORCEPS
MDR report key: 4302589
·
Received November 25, 2014
Report
- Report Number
- 4302589
- Event Type
- Malfunction
- Date Received
- November 25, 2014
- Date of Event
- November 24, 2014
- Report Date
- November 25, 2014
- Manufacturer
- SYMMETRY SURGICAL, A DIVISION OF SYMMETRY MEDICAL
- Product Code
- GDJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
Narratives
Description of Event or Problem · 1
DURING REVISION OF FEMORAL STEM WITH CONVERSION TO A HIP REPLACEMENT ON AN ELDERLY FEMALE, ALLIGATOR CLAMP BROKE. BROKEN PIECE OF INSTRUMENT RETRIEVED BY SURGEON WITH NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766415 | CODMAN HOEN ANGULAR FORCEPS | FORCEPS, GENERAL & PLASTIC SURGERY | GDJ | SYMMETRY SURGICAL, A DIVISION OF SYMMETRY MEDICAL | 30-1230 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | NOT KNOWN. |