| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CHISEL HANDLE | CHISEL, BONE, SURGICAL | SYNTHES BETTLACH | EML | 399.54 | 9132175 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-14 | 0 |
Patient 1
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. 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.
Patient 1
IT WAS REPORTED THAT THE SCREW THAT HOLDS THE CHISEL ONTO THE HANDLE BROKE DURING A SURGICAL PROCEDURE. ANOTHER INSTRUMENT WAS IMMEDIATELY AVAILABLE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient 1
ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 18 SEPTEMBER 2014. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE WAS 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.
Patient 1
ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND A SERVICE AND REPAIR EVALUATION WAS PERFORMED: THE CUSTOMER REPORTED THE SCREW THAT HELD THE CHISEL ON THE HANDLE BROKE. THE REPAIR TECHNICIAN REPORTED THE HEX SCREW WAS MISSING. MISSING PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: HEX SCREW I. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON 27-AUG-2015. THE EVALUATION WAS CONFIRMED. DEVICE WAS 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.
Patient 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.