| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE | GOUGE,SURGICAL,GEN & PLASTIC SURGERY | SYNTHES OBERDORF | GDH | 399.68 | 3957539 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-02-26 | 0 |
Patient 1
IT WAS REPORTED THAT THE HANDLE OF THE HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE WAS CRUMBLING AWAY. THIS WAS DISCOVERED AFTER STERILIZATION WHEN PUTTING THE EQUIPMENT AWAY IN THE CASE. THERE WERE MISSING FRAGMENTS. THERE WERE NO ISSUES WITH THE DEVICE PRIOR TO DISCOVERY. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient 1
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT 5057/3957539: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE HANDLE WAS FALLING APART. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS CRACKED AND BROKEN ON THE END. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED DEVICE SHOWS SIGNIFICANT USE DURING ITS 15+ YEAR LIFESPAN. THE BROWN HANDLE APPEARS TO BE DETERIORATING AND FLAKING OFF, WHILE THE METAL SHAFT IS SCRATCHED, GOUGED, AND DISCOLORED. DUE TO THE AGE OF THE DEVICE, THE DAMAGE IS MOST LIKELY DUE TO REPEATED STERILIZATION CYCLES OVER THE LIFE OF THE DEVICE. A VISUAL INSPECTION, DIMENSIONAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED AND DUE TO WEAR. THE RELEVANT DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. BECAUSE OF THIS, THE COMPLAINT IS DETERMINED NOT TO BE A RESULT OF A DETECTED DESIGN DEFICIENCY. THE RETURNED PART(S) ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, BUT THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. 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.