CHISEL-FLAT-STRAIGHT W/8
Report
- Report Number
- 8030965-2013-03694
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Report Date
- August 3, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- EML
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE BLADE OF THE CHISEL WAS PARTIALLY BROKEN OFF. ALL ARTICLES HAVE BEEN DISTRIBUTED WORLDWIDE AND WE ARE NOT AWARE OFF ANY OTHER SIMILAR BREAKAGES RELATED TO THE MENTIONED LOT NUMBER. THE MICROSCOPIC VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIAL STRUCTURE. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. THE INSTRUMENT MEETS FULLY TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.
IT WAS REPORTED THAT THE CHISEL BROKE DURING A TOTAL KNEE REPLACEMENT SURGERY. THE CHISEL WAS BEING USED ON PERIPROSTHETIC CEMENT. PRODUCT ONLY USED LESS THAN ONE YEAR AND WAS BROKEN. CUSTOMER COMPLAINED THAT THE PRODUCT IS NOT DURABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280790 | CHISEL-FLAT-STRAIGHT W/8 | EML | SYNTHES GMBH | 2715973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |