2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/4H SHAFT/LEFT
Report
- Report Number
- 8030965-2013-10614
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Report Date
- November 3, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K083694
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED NO VISIBLE MARKS OR DAMAGES. THERE WAS ALSO NO RUST DETECTED. THIS COMPLAINT WAS FOUND INDETERMINATE FROM A MANUFACTURING STANDPOINT.
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.
IT WAS REPORTED THAT 7 PLATES WERE FOUND, AND THEY APPEARED TO BE RUSTY. THIS IS 5 OF 7 REPORTS FOR THIS EVENT.
THIS IS REPORT 5 OF 7 FOR THIS COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124700 | 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/4H SHAFT/LEFT | HRS | SYNTHES GMBH | 3243921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |