FDA Adverse Event
Malfunction
Summary report: N
PATELLA CLAMP
MDR report key: 3056760
·
Received April 12, 2013
Report
- Report Number
- 0002249697-2013-01291
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
VISUAL AND FUNCTIONAL ANALYSIS CONFIRMED THE REPORTED EVENT. THE RATCHET SLIPS AND DOES NOT SECURELY LOCK. DEVICE HISTORY REVIEW INDICATES ALL PRODUCTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN OTHER EVENTS FOR THIS LOT. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE HAS BEEN PREVIOUSLY INVESTIGATED. AN ECN WAS IMPLEMENTED TO CORRECT THE REPORTED FAILURE. THE RETURNED DEVICE WAS CONFIRMED TO BE MANUFACTURED BEFORE THE ECN.
Description of Event or Problem · 1
THE PATELLA CLAMP WASN'T CLAMPING PROPERLY.
Description of Event or Problem · 1
THE PATELLA CLAMP WASN'T CLAMPING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158078 | PATELLA CLAMP | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |