KERRISON DET130 DEG UP 1MM 180MMTHP

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON DET130 DEG UP 1MM 180MMTHP (ITEM # FK906R) WAS USED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. X-RAY WAS USED TO RETRIEVE THE FRAGMENT FROM THE PATIENT. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, A SURGICAL DELAY OF FIFTEEN (15) MINUTES WAS NOTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - D4 (LOT #), D9, H4. INVESTIGATION: VISUAL INSPECTION OF THE PRODUCT REVEALED A BROKEN WORKING END OF THE PRODUCT. THE BROKEN OFF PART IS NOT AVAILABLE TO US FOR EXAMINATION. THE FRACTURE SURFACE SHOWS A FORCED DUCTILE BENDING FRACTURE. THE HARDNESS MEASUREMENT FOR THE SPECIFICATION OF 420+110 HV5 RESULTED IN A VALUE OF 472 HV5 WHICH CORRESPONDS TO THE SPECIFICATION. DEVICE HISTORY REVIEW: SINCE A REPAIR WAS PERFORMED AND THIS WAS IDENTIFIED AS THE CAUSE, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT NECESSARY. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE; SEVERITY WAS 3(5) AND PROBABILITY 3(5). EXPLANATION AND RATIONALE: NO DISCREPANCIES WERE FOUND DURING THE INSPECTION OF HARDNESS AND MATERIAL. ACCORDING TO BDOCS-AIM-117211 "PROOF OF PERFORMANCE KERRISON BONE PUNCHING", THE CAUSE IS HANDLING RELATED DUE TO OVERLOADING OF THE MATERIAL AND ASSOCIATED DESIGN. THE WORKING END OF THE BONE STEM WAS USED BEYOND ITS STABILITY LIMIT WHEREBY IT BROKE OFF. CONCLUSION AND PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE IS MOST LIKELY HANDLING - RELATED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.