FDA Adverse Event
Malfunction
Summary report: N
MIS REPLACEMENT INSERTER/EXTRACTOR PAD
MDR report key: 2042203
·
Received February 15, 2011
Report
- Report Number
- 1822565-2011-00610
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- January 24, 2011
- Report Date
- February 15, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: AS RETURNED, THE DEVICE IS FRACTURED. BASED ON LOT NUMBER, THE DEVICE HAS A POTENTIAL FIELD AGE OF LESS THAN A YEAR AND HAS BEEN USED AN UNK NUMBER OF TIMES DURING THAT PERIOD. IMPACTORS BECOME DAMAGED THROUGH REPEATED USE IN THE FORM OF IMPACTION. NORMAL WEAR AND TEAR IS THE MOST LIKELY CAUSE OF FAILURE. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. DIMENSIONAL READINGS ARE CONFORMING TO PRINT SPECIFICATIONS. NO MFG ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPACTION PAD OF INSERTER/EXTRACTOR BROKE DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIS REPLACEMENT INSERTER/EXTRACTOR PAD | HWA | ZIMMER INC | 61594616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |