ACCULAN 4 DRILL AND REAMER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 - DEVICE EVALUATION COMPLETED. H6 - CODES UPDATED. BASED UPON INVESTIGATION RESULTS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE DUE TO RISK FILE- NO MALFUNCTION OR SERIOUS INJURY. SEVERITY DECREASED FROM 3(5) TO 2(5). INVESTIGATION RESULTS: VISUAL INVESTIGATION: WE RECEIVED A GA330 IN A DECONTAMINATED AND USED CONDITION.THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICE (ATS).THE INVESTIGATION SHOWED THAT THE STATOR IS SWOLLEN, THIS CAUSED THE BALL BEARING TO STUCK AND THE ROTOR GOT DAMAGED. IN ADDITION RESIDUES COULD BE FOUND INSIDE THE HOUSING. 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 1(5) OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: A CLEAR CONCLUSION CANNOT BE DRAWN. THE DHR FILES ARE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MANUFACTURING FAILURE. SINCE THE MAINTENANCE DATE WAS DUE IN JULY 2022, IT COULD BE POSSIBLE THAT WEAR AND TEAR AND / OR A LACK OF MAINTENANCE LED TO THE DESCRIBED PROBLEM. HOWEVER, THIS IS ONLY SPECULATIVE. 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 GA330 - ACCULAN 4 DRILL AND REAMER. ACCORDING TO THE COMPLAINT DESCRIPTION, THE ACCULAN HEATED AND STOPPED. PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).