4.5MM X 150MM LIBERATOR KNIFE

Additional Manufacturer Narrative

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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. DEVICE NOT YET RECEIVED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DEVICE 25.50014, 4.5MM X 150MM LIBERATOR KNIFE, WAS BEING USED ON (B)(6) 2023 DURING A SHOULDER ARTHROSCOPY PROCEDURE WHEN IT WAS REPORTED ¿DURING THE SURGERY PART OF THE DEVICE WAS BROKEN. A SMALL PART FELL INTO THE PATIENT¿S BODY. IT IS STILL INSIDE THE PATIENT. NO INFECTION IS ANTICIPATED BY THE SURGEON THEREFORE, THE SURGEON¿S DECISION WAS TO KEEP IT, AND NOT TO PERFORM ANOTHER SURGERY TO PULL IT OFF. THE TIME OF THE SURGERY WAS 3 HOURS. THE CONDITION OF THE PATIENT (MALE) IS GOOD. AND THE PURPOSE OF THE SURGERY COMPLETED SUCCESSFULLY.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO PATIENT RETAINING A FOREIGN OBJECT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DEVICE 25.50014, 4.5MM X 150MM LIBERATOR KNIFE, WAS BEING USED ON (B)(6) 2023 DURING A SHOULDER ARTHROSCOPY PROCEDURE WHEN IT WAS REPORTED ¿DURING THE SURGERY PART OF THE DEVICE WAS BROKEN. A SMALL PART FELL INTO THE PATIENT¿S BODY. IT IS STILL INSIDE THE PATIENT. NO INFECTION IS ANTICIPATED BY THE SURGEON THEREFORE, THE SURGEON¿S DECISION WAS TO KEEP IT, AND NOT TO PERFORM ANOTHER SURGERY TO PULL IT OFF. THE TIME OF THE SURGERY WAS 3 HOURS. THE CONDITION OF THE PATIENT (MALE) IS GOOD. AND THE PURPOSE OF THE SURGERY COMPLETED SUCCESSFULLY.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO PATIENT RETAINING A FOREIGN OBJECT.

Additional Manufacturer Narrative

EXAMINATION OF THE RETUNED USED DEVICE, ITEM 25.50014 CONFIRMS THE REPORTED PROBLEM AND FOUND DEVICE TIP BROKEN OFF. BROKEN TIP WAS NOT RETURNED FOR THE EVALUATION. BROKEN TIP WAS DAMAGED AT THE CUTTING EDGES. EXAMINATION WAS PERFORMED PER PRINT A55-850-126; COULD NOT FIND ANY ISSUES WITH CRITICAL DIMENSIONS. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE, PICTURES, AND ENGINEERING INPUT; POTENTIAL CAUSES OF THE FAILURE ARE EXCESSIVE FORCE PLACED ON THE SHAFT AND INCORRECT MATERIALS USED FOR INSTRUMENT CONSTRUCTION. ALTHOUGH THIS IS A REUSABLE DEVICE, IT IS NOT SERVICEABLE. THEREFORE, A SERVICE HISTORY IS NOT AVAILABLE FOR REVIEW. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A CONMED LOT NUMBER WAS NOT PROVIDED. AS A CONMED LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE SPECIFIC LOT HISTORY RECORD WAS NOT COMPLETED. INSTEAD, A REVIEW OF THE NON-CONFORMANCE HISTORY FOR THE ITEMS WAS CONDUCTED. A REVIEW OF NCS FROM 01-JUN-2009 TO 30-JUN-2023 FOR 25.50014 SHOWED NO ATTRIBUTABLE TRENDS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 2 COMPLAINTS, REGARDING 2 DEVICES, FOR THIS DEVICE 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 0.003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED PRIOR TO USE CLEANING OR STERILIZATION, REMOVE ALL PROTECTIVE PACKAGING AND TIP PROTECTOR, IF APPLICABLE. INSPECT INSTRUMENTS PRIOR TO USE TO ENSURE PROPER FUNCTION; NO LOOSE PINS OR MISALIGNMENT, AND THAT THE INSTRUMENT IS IN GOOD PHYSICAL CONDITION. INSPECT INSTRUMENTS AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.