| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CHISEL HANDLE | CHISEL, BONE, SURGICAL | SYNTHES BETTLACH | EML | 399.540 | 2255902 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-26 | 0 |
Patient 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IT WAS DISCOVERED THAT THE SCREW FROM THE CHISEL HANDLE IS MISSING. THE CHISEL CAN BE REMOVED FROM THE HANDPIECE. IT IS UNKNOWN WHEN THE SCREW LOST BUT THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED ISSUE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient 1
ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION SUMMARY: THE INVESTIGATION OF THE CHISEL HANDLE SHOWS THAT THE TIGHTENING SCREW IS MISSING. THE ARTICLE SHOWS A LOT OF WEAR MARKS ON THE WHOLE ARTICLE. UNFORTUNATELY, WITHOUT MORE INFORMATION, IT CANNOT BE DETERMINED THE EXACT CAUSE WHICH LEAD TO THIS OCCURRENCE. AS THE TIP OF THE SCREW IS DESIGNED IN SUCH A WAY THAT THE FIXATION SCREW CANNOT BE UNSCREWED FROM THE BOLT, IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING USE. PLEASE NOTE, THAT THE SCREW HAS A STOP AND THEREBY IT IS IMPOSSIBLE TO UNSCREW THIS GIVEN DESIGN. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WAS NO ISSUE DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO PRODUCT FAULT COULD BE DETECTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.