FDA Adverse Event
Malfunction
Summary report: N
LOCKING FEMORAL IMPACTOR
MDR report key: 3970277
·
Received April 30, 2014
Report
- Report Number
- 1038671-2014-00153
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- March 26, 2014
- Report Date
- April 30, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- HWA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING FACILITY IS AWAITING EVALUATION OF THE DEVICE.
Description of Event or Problem · 1
DURING THE POST-OPERATIVE X-RAY, SURGEON NOTED A METAL SUBSTANCE NEAR THE TIBIAL TRAY. THE INSTRUMENTS WERE VERIFIED AND IT WAS DISCOVERED THAT A SCREW HAD DISASSOCIATED FROM THE IMPACTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258866 | LOCKING FEMORAL IMPACTOR | LOCKING FEMORAL IMPACTOR | HWA | EXACTECH, INC. | 201-64-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |