KERRISON DET130 DEG UP 1MM 180MMTHP

Additional Manufacturer Narrative

UPDATED H6: CODES. BASED UPON INVESTIGATION RESULTS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE DUE TO RISK FILE- NO MALFUNCTION OR SERIOUS INJURY.  INVESTIGATION RESULTS: VISUAL INVESTIGATION: PRODUCTS AVAILABLE FOR INVESTIGATION IN A DECONTAMINATED CONDITION. THE KERRISON IS SHOWING A DEFORMATION ON THE FOOTPLATE. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. DURING THE INVESTIGATION OF THE PUNCH IT WAS FOUND, THAT THE FOOTPLATE IS BENT DOWN ON THE WORKING END. 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. 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

ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00617 ((B)(4) - FK906R). 9610612-2020-00618 ((B)(4)- FK914R). 9610612-2020-00619 ((B)(4)- FK915R). 9610612-2020-00620 ((B)(4) - FK915R).

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 A BONE PUNCH. ACCORDING TO THE COMPLAINT DESCRIPTION THE TIPS OF THE DEVICES BENT DURING SURGERY. 4 DEVICES WERE INVOLVED IN THIS COMPLAINT (SEE ASSOCIATED MEDWATCH REPORTS BELOW) MOST OF THE ISSUE IS REGARDING THE BENT TIPS; SPECIFICALLY THE SHARP CUTTING SURFACE IS BENT BACKWARDS. THESE CAN BE SEEN ON THE 4MM REGULAR FOOTPLATE, THE 3MM FOOTPLATE AND THE 1MM AS WELL. THE FOUR DEVICES HAD FAILED DURING A LAMINECTOMY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS BACK UP DEVICES WERE READILY AVAILABLE. THERE WAS REPORTEDLY NO IMPACT TO THE PATIENT AND NO DELAY IN ANY PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: (B)(4). 9610612-2020-00618 (B)(4). 9610612-2020-00619 (B)(4). 9610612-2020-00620 (B)(4).