KERRISON DET130 DEG UP 3MM 180MM.REG

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK902R - KERRISON DET130 DEG UP 3 MM 180 MM.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: (400558510 - FK902R). 9610612-2022-00137 (400558543 - FK902R). 9610612-2022-00162 (400558542 - FK902R).

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

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 PRODUCTS. HARDNESS TEST WAS PERFORMED AND ALL INSTRUMENTS 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 IS ONE SIMILAR COMPLAINT 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. EXPLANATION AND RATIONALE: THERE ARE NO INDICATIONS OF PREVIOUS DAMAGE OR SIMILAR. THE REASON FOR THE DEVIATION CANNOT BE DETERMINED AT THIS TIME. WE ARE IN EXCHANGE WITH MARKETING AND R&D TO AGREE ON FURTHER PROCEDURES REGARDING THIS DEVIATION. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA WAS NOT NECESSARY.