ACCULAN 3TI DRILL AND REAMER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION/CORRECTION: B5: INVOLVED COMPONENTS ADDED. D10: INVOLVED COMPONENTS ADDED. H6: CODES UPDATED. INVESTIGATION RESULTS: (FINAL RESULTS): THE INVESTIGATION WAS CARRIED OUT BY OUR TECHNICIANS IN THE AESCULAP TECHNICAL SERVICES (ATS), AND BASED ON THE STATEMENT OF THE TECHNICIANS FOLLOWING DEVIATION WERE DETECTED: GA672. INTERIOR CORROSION: ROTOR SWOLLEN; BALL BEARINGS DEFECTIVE, STUCK IN STATOR. GB638R: CERAMIC PIN IS SHEARED OFF AND WE FOUND RESIDUES INSIDE THE PRODUCT. GB660R: RESIDUES INSIDE THE PRODUCT AND BALL BEARING WERE DAMAGED. DEVICE HISTORY RECORDS: PRODUCT QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) WERE REVIEWED FOR ALL LOT NUMBERS OF THE LEADING DEVICES AND THE PRODUCTS MET OUR SPECIFICATIONS IN PLACE AT THE TIME OF MANUFACTURE. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE; SEVERITY WAS UPDATED TO 5(10) AND PROBABILITY 3 (5). EXPLANATION AND RATIONALE: DURING THE FAULT ANALYSIS, CORROSION WAS FOUND IN THE INTERIOR AND THE ROTOR, STATOR AND BALL BEARINGS WERE DAMAGED AS A RESULT. FURTHERMORE WE HAVE DETECTED THAT THE CERAMIC PIN FOR GB638R IS SHEARED OFF. THIS COULD ALSO LEAD TO THE MENTIONED DEVIATION. ACCORDING TO OUR HYPOTHESIS, THIS DEFECT IS DUE TO LACK OF CARE AND MAINTENANCE. DELIVERY DATE 10.2018, A MAINTENANCE (WD 12.2019) OR REPAIR IS NOT TRACEABLE IN THE SAP. THE DEVICE INSTRUCTION MANUAL POINTS OUT THE NEED FOR FUNCTIONAL INSPECTIONS, MAINTENANCE AND TESTING, AND PROPER CARE FOR REUSABLE PRODUCTS. THE PRODUCT IS OUT OF WARRANTY. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE MOST PROBABLE ROOT CAUSE IS HANDLING AND REPROCESSING - RELATED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

UPDATE: INVOLVED COMPONENTS ADDED. INVOLVED COMPONENTS: GB638R/ ACCULAN 3TI DRILL ATTACHM. LARGE JACOBS - LOT: 52459786. GB660R/ ACCULAN SAGITTAL SAW ATTACHMENT - LOT: 52458486.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 - PRODUCT RETURN DATE. H4 - MANUFACTURE DATE. H3 - NOT YET FINAL. H6 - CODES UPDATED. INVESTIGATION RESULTS(UPDATED): FINAL RESULTS PENDING.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 - PRODUCT NOT RETURNED. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED, AND A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. 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. THE BATCH-RELATED COMPLAINT HISTORY REVIEW DID NOT REVEAL ANY SIMILAR COMPLAINTS FOR THE REPORTED FAILURE MODE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: UNFORTUNATELY, WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT ROOT CAUSE. THEREFORE THE ROOT CAUSE SPECIFIC RISK CANNOT BE IDENTIFIED. THE POTENTIAL RISK DETERMINED DURING INITIAL VIGILANCE EVALUATION REMAINS VALID. ACCORDING TO THE QUALITY STANDARD AND DHR FILES A MATERIAL DEFECT AND A PRODUCTION ERROR CAN BE EXCLUDED. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FURTHER INVESTIGATION WILL BE PERFORMED AT THAT TIME. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA672 - ACCULAN 3TI DRILL AND REAMER. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT LOCKED AND DID NOT WORK CORRECTLY. THE MALFUNCTION WAS INTERMITTENT DURING SURGERY IN (B)(6) 2022; BACKUP LOAN EQUIPMENT WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS TO TREAT A FRACTURED HUMERUS ("ACVC"). AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS NOTED AS "RECOVERED". THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.