BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/
Report
- Report Number
- 8030965-2013-03343
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- September 8, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HXZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CE
- 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. DEVICE MANUFACTURE DATE WAS 03/04/2004. THE DEVICE HISTORY RECORDS WERE REVIEWED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(6). 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. PRO CODES: HTZ, FZT. A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE BOLT CUTTING HEAD IS BROKEN. OUR INVESTIGATION FOUND THAT A PIECE ON THE CUTTING HEADS BODY ON THE TIP BROKE OFF. THE HARDNESS AND DIMENSIONS WERE FOUND TO MEET OUR SPECIFICATIONS. WE ARE NOT ABLE TO RELIABLY DETERMINE A CAUSE FOR THE BREAKAGE. NO PRODUCT FAULT OR MATERIAL RELATED CONDITION WAS FOUND.
IT WAS REPORTED THAT THE BOLT CUTTING HEAD WAS BROKEN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290445 | BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/ | HXZ | SYNTHES GMBH | 1247924 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |