KERRISON 15MM NOIR 130DEG UP 200MM 3MM

Additional Manufacturer Narrative

BASED UPON INVESTIGATION RESULTS (NO FAILURE DETECTED), THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE DUE TO RISK FILE- NO MALFUNCTION OR SERIOUS INJURY. INVESTIGATION RESULTS/ VISUAL INVESTIGATION: WE RECEIVED IN TOTAL 20 KERRISON PUNCHES IN DIFFERENT CONDITIONS. FIVE OF THEM SHOWED A BENT-DOWN WORKING END. TWO OF THEM SHOWED A BENT-UP CUTTING EDGE ON THE UPPER SLIDER PART. AND THIRTEEN OF THEM DIDN'T SHOW ANY FAILURE. INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. DURING THE INVESTIGATION THE FOOTPLATE OF FIVE PUNCHES HAVE BEEN FOUND TO BE BENT DOWNWARDS AND THERE WERE DAMAGES ON THE CUTTING EDGE OF THE UPPER SLIDER PART. FURTHERMORE THE CUTTING EDGE OF THE UPPER SLIDER PART OF TWO PUNCHES IS BENT-UP. IN BOTH CASES WE ASSUME THAT THIS DEFORMATION HAS BEEN CAUSED DUE TO AN OVERLOAD SITUATION DURING THE PROCEDURE ITSELF. A HINT CAN BE FOUND IN THE INSTRCTION FOR USE REGARDING OVERLOADING. "DAMAGE TO OR DESTRUCTION OF THE PRODUCT CAUSED BY INCORRECT HANDLING! USE THE PRODUCT ACCORDING TO INDENDED USE: AVOID OVERSTRAINING THE PRODUCT BY TURNING OR LEVERING MOVEMENTS DURING THE PUNCHING PROCEDURE USE KERRISON BON PUNCHES WITH THIN FOOT PLATE ONLY FOR REMOVING SMALL, SOFT BONE PARTS AND TISSUE. PUCH ONLY AS MUCH TISSUE AS THE CAVITY BETWEEN FOOT AND SLIDER PART CAN ACOMMODATE." (EXPERT OF INSTRUCTION FOR USE (IFU) OF KERRISON BONE PUNCHES). THIS CAN BE UNDERLINED BY THE DENT WE FOUND DURING INVESTIGATION, AS THIS CAN BE CONSIDERED AS A SIGN OF AN OVERLOADING SITUATION. WE WERE NOT ABLE TO DETECT ANY HINT FOR A MATERIAL DEFECT OR A PRODUCTION ERROR. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THERE IS ONE SIMILAR COMPLAINT AGAINST LOT NUMBER 4510949504. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 2(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

Description of Event or Problem

AAG REFERENCE NUMBER: (B)(4). THE MALFUNCTIONS OCCURRED DURING LUMBAR SPINAL PROCEDURES, AND LESS THAN A FIVE MINUTE DELAY IN THE PROCEDURES AS BACK-UP DEVICES WERE READILY AVAILABLE TO COMPLETE THE SURGERIES. ASSOCIATED MEDWATCHES: 9610612-2021-00243, 9610612-2021-00244, 9610612-2021-00245, 9610612-2021-00246, 9610612-2021-00247, 9610612-2021-00248, 9610612-2021-00249, 9610612-2021-00251, 9610612-2021-00253, 9610612-2021-00252, 9610612-2021-00254, 9610612-2021-00250, 9610612-2021-00255, 9610612-2021-00262, 9610612-2021-00261, 9610612-2021-00260, 9610612-2021-00259, 9610612-2021-00258, 9610612-2021-00257, AND 9610612-2021-00256.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK982B - KERRISON 15MM NOIR 130DEG UP 200MM 3MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE BENT WHILE CUTTING. THIS MALFUNCTION PROLONGED THE SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).