KERRISON DETACH 130DG UP 200MM 1MM THIN

Additional Manufacturer Narrative

UPDATED D4: LOT NUMBER. H4- MANUFACTURE DATE. UPDATED H6: CODES. INVESTIGATION RESULTS: VISUAL INVESTIGATION: PRODUCT AVAILABLE FOR INVESTIGATION IN A DECONTAMINATED CONDITION. THE KERRISON PUNCH SHOWS A BROKEN FOOTPLATE. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE FOOTPLATE IS TOTALLY BROKEN OFF. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. 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.

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 FK961B-KERRISON DETACH 130DG UP 200MM 1MM THIN. THE TIP OF THE DEVICE BROKE DURING USE IN A C4-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AS THE PIECE WAS EASILY VISIBLE. AN X-RAY WAS NOT REQUIRED; THERE WAS LESS THAN 5 MINUTE DELAY REQUIRED TO REPLACE THE INSTRUMENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE FRAGMENT WAS NOTED TO BE EXTREMELY SMALL. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).