KERRISON 15MM NOIR 130DEG UP 200MM 4MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: WE RECEIVED FIVE BONE STAMPS FOR EXAMINATION, ONE HAD THE TIP BENT UPWARDS. INVESTIGATION RESULT: THE FUNCTION TEST WITH AN EMPTY BONE PUNCH WAS POSITIVE FOR ALL OF THEM - THIS MEANS THAT THE BONE PUNCHES COULD BE OPERATED WITHOUT PROBLEMS AND THE UPPER SLIDE MOVED BACK INTO ITS ORIGINAL POSITION. THE CUTTING TEST ALSO COMPLIED WITH THE SPECIFICATIONS OF THE TEST PLAN, WITH THE EXCEPTION OF THE TOOL WITH THE BENT-UP TIP, WHICH ALSO DID NOT JAM. CONCLUSION ROOT CAUSE ANALYSIS DESCRIPTION ROOT CAUSE: THE ERROR REGARDING THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED - THE BONE PUNCHES ARE WORKING ACCORDING TO THE SPECIFICATION. PLEASE PAY ATTENTION TO THE IFU (FIG.4). WE CAN EXCLUDE A PRODUCTION-RELATED CAUSE BASED ON THE CURRENT ANALYSIS RESULTS. DETAILS ON ROOT CAUSE: N/A DEVICE HISTORY RECORD REVIEW RESULTS OF REVIEW DEVICE HISTORY RECORDS (DHR): THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR THIS PRODUCT AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN.

Description of Event or Problem

INVESTIGATION COMPLETE.

Description of Event or Problem

IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON 15MM NOIR 130DEG UP 200MM 4MM (MATERIAL # FK983B) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE DEVICE BECAME STUCK AFTER TAKING A BONE BITE. REPORTEDLY, THE PHYSICIAN ENCOUNTERED PHYSICAL RESISTANCE WHILE ATTEMPTING TO ACTUATE THE HANDLE, WHICH REQUIRED HIM TO USE TWO (2) HANDS TO FORCIBLY RELEASE AND RETRIEVE THE BONE SPECIMEN. PRIOR TO TAKING THE BITE, THE HANDLE FUNCTIONED PROPERLY WITH SMOOTH ACTUATION NOTED. HOWEVER, AFTER TAKING THE BONE BITE, THE DEVICE JAMMED. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY TO RETRIEVE THE DISLODGED BONE FRAGMENT. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.