C-WIRE
Received Nov 26, 2024 · Event occurred Dec 10, 2021
Report 1017294-2024-00140 · MDR key 20784156
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00505004200, PAK DOUBLE ENDED ORTHOPAEDIC WIRE,SPADE,.035", WAS BEING USED ON AN UNKNOWN DATE AND THE ¿C-WIRE (00505004200) WAS BROKEN DURING A HAND SURGERY. IT REQUIRED SURGEON TO TRIM THE BONE TO REMOVE C-WIRE BROKEN IN FIGURE. AS A RESULT, EXTENSION LAG AND PAIN HAS BEEN REMAINED ON PATIENT¿ SURGEON USED C-WIRE WITH STRYKER REM-B HANDPIECE.¿. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF TRIMMING THE BONE TO REMOVE THE BROKEN C-WIRE.
Additional Manufacturer Narrative
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 4 REPORTS, REGARDING 4 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 308,126 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 (B)(4). WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
Description of Event or Problem
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00505004200, PAK DOUBLE ENDED ORTHOPAEDIC WIRE, SPADE,.035", WAS BEING USED ON 10DEC21 AND THE ¿C-WIRE (00505004200) WAS BROKEN DURING A HAND SURGERY. IT REQUIRED SURGEON TO TRIM THE BONE TO REMOVE C-WIRE BROKEN IN FIGURE. AS A RESULT, EXTENSION LAG AND PAIN HAS BEEN REMAINED ON PATIENT¿ SURGEON USED C-WIRE WITH STRYKER REM-B HANDPIECE.¿. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF TRIMMING THE BONE TO REMOVE THE BROKEN C-WIRE.