OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5
Report
- Report Number
- 1017294-2021-00371
- Event Type
- Malfunction
- Date Received
- December 15, 2021
- Report Date
- December 15, 2021
- Manufacturer
- CONMED LARGO
- Product Code
- GFA
- UDI-DI
- 10845854021439
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- 003
Narratives
THE REPORTED EVENT OF ¿BROKEN TANGS ON HAND PIECE END OF BLADE¿ IS CONFIRMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; HOWEVER, THE PROVIDED PHOTOGRAPHIC EVIDENCE EXHIBITS THE REPORTED EVENT THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 3 COMPLAINTS, REGARDING 3 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.000009. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: DO NOT APPLY EXCESSIVE LOADING ON THE SHAVER BLADE OR BUR. CUTTING PERFORMANCE IS NOT INCREASED WITH FORCE. EXCESSIVE FORCE OR USING SHAVER BLADES OR BURS AS A LEVER CAN CAUSE DAMAGE TO THE DEVICE INCLUDING PERMANENT DEFORMATION, SHEDDING OF METAL (WEAR) MOTOR SEIZURE AND OVERHEATING. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE REPORTED EVENT OF ¿BROKEN TANGS ON HAND PIECE END OF BLADE¿ IS CONFIRMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; HOWEVER, THE PROVIDED PHOTOGRAPHIC EVIDENCE EXHIBITS THE REPORTED EVENT THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 3 COMPLAINTS, REGARDING 3 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.000009. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: DO NOT APPLY EXCESSIVE LOADING ON THE SHAVER BLADE OR BUR. CUTTING PERFORMANCE IS NOT INCREASED WITH FORCE. EXCESSIVE FORCE OR USING SHAVER BLADES OR BURS AS A LEVER CAN CAUSE DAMAGE TO THE DEVICE INCLUDING PERMANENT DEFORMATION, SHEDDING OF METAL (WEAR) MOTOR SEIZURE AND OVERHEATING. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE V190-119-90,OSCILLATING SAW BLADE WAS BEING USED ON AN UNKNOWN DATE SOMETIME DURING THE (B)(6), 2021 DURING A JOINT REPLACEMENT PROCEDURE WHEN IT WAS REPORTED ¿FOUND BROKEN METALLIC BIT ON TABLE AFTER SAW BLADE USE, CONFIRMED MISSING PIECES FROM SAW BLADE. RECOVERED 2 PIECES, CAN PUT ENTIRE BLADE BACK TOGETHER, NO MISSING PIECE. FLUOROSCOPY CONFIRMED NO METALLIC FB IN PATIENT.¿ THERE WAS NO REPORT OF IMPACT/INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE (B)(4), OSCILLATING SAW BLADE WAS BEING USED ON AN UNKNOWN DATE SOMETIME DURING THE 1ST WEEK OF NOVEMBER, 2021 DURING A JOINT REPLACEMENT PROCEDURE WHEN IT WAS REPORTED ¿FOUND BROKEN METALLIC BIT ON TABLE AFTER SAW BLADE USE, CONFIRMED MISSING PIECES FROM SAW BLADE. RECOVERED 2 PIECES, CAN PUT ENTIRE BLADE BACK TOGETHER, NO MISSING PIECE. FLUOROSCOPY CONFIRMED NO METALLIC FB IN PATIENT.¿ THERE WAS NO REPORT OF IMPACT/INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1905123 | OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5 | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | GFA | CONMED LARGO | V190-119-90 | 1126049 | 10845854021439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | X-RAY TAKEN 1ST WEEK OF (B)(6) 2021. |