CANCELLOUSSCR Ø4 FULL-THR L16 TI
Report
- Report Number
- 8030965-2013-03254
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- November 21, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- KWQ
- PMA / PMN Number
- K925351
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. ADDITIONAL INFO: DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.
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. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE SCREW WAS OUT OF SPECIFICATION, 2MM LONGER. THE INVESTIGATION OF THE COMPLAINED CANCELLOUS SCREW SHOWS THAT THE TIP ON THE THREAD DOES NOT CORRESPOND TO OUR SPECIFICATIONS. ONE CYCLE DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT AS INTENDED.
IT WAS REPORTED THAT THE SCREW WAS 2MM LONGER THAN ITS STATED SPECIFICATIONS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290801 | CANCELLOUSSCR Ø4 FULL-THR L16 TI | KWQ | SYNTHES GMBH | 2728143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |