KERRISON DET130 DEG UP 3MM 180MM.REG

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 FK902R - KERRISON DET130 DEG UP 3MM 180MM.REG. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT(S) HAD SHARP/CUTTING EDGES. A LACERATION OF THE DURA MATER OCCURRED, WHICH REQUIRED SUTURING; THE SURGEON COMPLETED THE SUTURING. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00161 (400558510 - FK902R), 9610612-2022-00137 (400558543 - FK902R) AND 9610612-2022-00162 (400558542 - FK902R).

Description of Event or Problem

ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00161 (400558510 - FK902R), 9610612-2022-00137 (400558543 - FK902R), 9610612-2022-00162 (400558542 - FK902R).

Additional Manufacturer Narrative

INVESTIGATION: VISUAL INVESTIGATION: WE OBSERVED A DEFORMED TIP OF THE PRODUCT. WE ALSO NOTICED DEVIATIONS OF THE SURFACE; THE LABELING WAS TAPED OFF AND THE SURFACE WAS FINISHED TO A DIFFERENT STANDARD THAN AAG SPECIFICATIONS. IN ADDITION, AN UNKNOWN MARK OR CODE WAS APPLIED TO THE INSTRUMENT; THIS INDICATES A THIRD-PARTY REPAIR. HARDNESS TEST WAS PERFORMED AND THE INSTRUMENT COMPLIED WITHIN THE SPECIFICATIONS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE TWO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL ((2)5 SEVERITY X (2)5 PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY MAINTENANCE-RELATED (THIRD-PARTY REPAIR). THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA WAS NOT NECESSARY.