CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEGREE

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER TECOMET IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE.

Description of Event or Problem

THIS IS A VOLUNTARY DISTRIBUTOR REPORT THE CUSTOMER REPORTED THAT A NEEDLE OF THE C6856, CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEGREE, WAS FOUND TO HAVE THE PINS MISSING AFTER USE. DURING A MENISCECTOMY PROCEDURE ON (B)(6) 2018, THE SURGEON NOTICED THAT THE PINS OF THE JAW WERE MISSING FROM THE DEVICE. THE USER DOES NOT KNOW IF THE PINS CAME LOOSE BEFORE OR DURING THE SURGERY. THE MISSING PINS WERE NOT LOCATED. THE PROCEDURE WAS COMPLETED AS NORMAL WITH NO DELAY REPORTED. THE STATUS OF THE PATIENT IS REPORTED AS NORMAL. THERE WAS NO EXTENDED STAY IN THE HOSPITAL. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT ON THE BASIS OF INJURY TO THE PATIENT SINCE THE PINS WERE NOT LOCATED AFTER THE SURGERY.

Additional Manufacturer Narrative

CORRECTION: INITIALLY THIS REPORT WAS LISTED AS A VOLUNTARY DISTRIBUTOR REPORT; HOWEVER, THE DESIGN DOES BELONG TO CONMED. THEREFORE, THIS CORRECTION IS SUBMITTED CORRECTION TO CONTACT OFFICE. CORRECTION TO EVALUATION, INVESTIGATION AND REPORT OF ANY REMEDIAL ACTIONS FROM CONTRACT MANUFACTURER TO CONMED. THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE NEEDLE OF THE C6856, CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEGREE, WAS FOUND TO HAVE THE PINS MISSING AFTER USE. DURING THE MENISCECTOMY PROCEDURE ON (B)(6) THE SURGEON NOTICED THAT THE PINS OF THE JAW WERE MISSING FROM THE DEVICE. THE USER DOES NOT KNOW IF THE PINS CAME LOOSE BEFORE OR DURING THE SURGERY. THE MISSING PINS WERE NOT LOCATED. THE PROCEDURE WAS COMPLETED AS NORMAL WITH NO DELAY REPORTED. THE STATUS OF THE PATIENT IS REPORTED AS NORMAL. THERE WAS NO EXTENDED STAY IN THE HOSPITAL. THE REPORT IS BEING RAISED ON THE BASIS OF INJURY TO THE PATIENT SINCE THE PINS WERE NOT LOCATED AFTER THE SURGERY.

Additional Manufacturer Narrative

THE ALLEGED BROKEN C6856, CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEGREE, WAS NOT RETURNED FOR EVALUATION AND REVIEW. THIS COMPLAINT OF "SHAFT (PINS) OF THE JAW COMES OUT FROM THE HOLE" IS UNABLE TO BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. THE SERVICE HISTORY FOR THIS DEVICE WAS REVIEWED AND IT WAS FOUND THAT THE DEVICE WAS LAST SERVICED IN OCTOBER OF 2017. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN THIS ONE COMPLAINT, REGARDING THIS ONE DEVICE, FOR THIS DEVICE AND FAILURE MODE. DURING THIS SAME TIME FRAME 552 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 0.002. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PRECAUTIONS: - INSPECT THE INSTRUMENT PRIOR TO USE TO ENSURE IT IS IN GOOD PHYSICAL CONDITION AND FUNCTIONS PROPERLY. THERE SHOUL BE NO LOOSE, BROKEN OR MISALIGNED PARTS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.