FDA Adverse Event
Malfunction
Summary report: N
TIBIAL IMPACTOR
MDR report key: 912575
·
Received September 13, 2007
Report
- Report Number
- 1644408-2007-00178
- Event Type
- Malfunction
- Date Received
- September 13, 2007
- Date of Event
- August 21, 2007
- Report Date
- September 13, 2007
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS A MULTI-USE INSTRUMENT THAT IS STERILIZED AT THE HOSPITAL. LOT NUMBER INFORMATION WAS NOT PROVIDED, SO MANUFACTURING INFORMATION CANNOT BE REVIEWED.
Description of Event or Problem · 1
PATIENT RETURNED TO SURGERY TO RETRIEVE SMALL PIECE THAT BROKE OFF THE IMPACTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIBIAL IMPACTOR | HWA | ENCORE MEDICAL, L.P. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |