KERRISON DET130 DEG UP 2MM 180MM

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 FK901R - KERRISON DET130 DEG UP 2MM 180MM. ACCORDING TO THE COMPLAINT DESCRIPTION, A BARB WAS NOTED ON THE UPPER CUTTING EDGE(S). DURING A LUMBAR DECOMPRESSION, AN APPROXIMATELY 0.5 INCH DURAL TEAR OCCURRED. THIS RESULTED IN LONGER EXPOSURE TO ANESTHETIC IN ORDER TO REPAIR THE TEAR (40 EXTRA MINUTES REQUIRED). A MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS "FINE". ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00108 (400555282 - FK902R), 9610612-2022-00154 (400555283 - FK902R).

Description of Event or Problem

ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00108 (400555282 - FK902R). 9610612-2022-00154 (400555283 - FK902R).

Additional Manufacturer Narrative

INVESTIGATION RESULTS: VISUAL INVESTIGATION: WE OBSERVED A DEFORMED TIP ON THE PRODUCTS. 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. EXPLANATION AND RATIONALE: THERE ARE NO INDICATIONS OF PREVIOUS DAMAGE OR SIMILAR. WE CAN RULE OUT A MANUFACTURING RELATED CAUSE BASED N THE CURRENT ANALYSIS RESULTS. THE REASON FOR THE DEVIATION CANNOT BE DETERMINED. 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 CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.