FDA Adverse Event
Malfunction
Summary report: N
MIS FEMORAL INSERTER/EXTRACTOR
MDR report key: 2122008
·
Received May 24, 2011
Report
- Report Number
- 1822565-2011-01213
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 28, 2011
- Report Date
- April 28, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: AS RETURNED, THE IMPACTOR PAD IS FRACTURED. BASED ON THE LOT NUMBER, THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 10 MONTHS AND HAS BEEN USED AN UNKNOWN NUMBER OF TIMES DURING THAT PERIOD. IN GENERAL, IMPACTORS BECOME DAMAGED THROUGH REPEATED USE DUE TO IMPACTIONS SUSTAINED WHILE IN USE. IMPACTORS OR IMPACTOR HEADS SHOULD BE REPLACED WHEN THE PART IS NO LONGER FUNCTIONING. EVALUATION CODES: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PLASTIC PIECE BROKE OFF DURING IMPACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIS FEMORAL INSERTER/EXTRACTOR | HWA | ZIMMER, INC. | 61523502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |