ACCULAN 4 DRILL AND REAMER

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 DRILL WAS NOISY AND HEATED QUICKLY. PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 - DEVICE EVALUATION. H6 - CODES UPDATED. 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). BATCH HISTORY REVIEW: SINCE A REPAIR WAS PERFORMED AND THIS WAS IDENTIFIED AS THE CAUSE, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT NECESSARY. EXPLANATION AND RATIONALE: THE INVESTIGATION SHOWED THAT THE STATOR IS SWOLLEN, THIS CAUSED THE BALL BEARING TO STUCK AND CAUSED THE MOTOR TO STOP. IN ADDITION, OP RESIDUES AND CORROSION COULD BE FOUND INSIDE. A CLEAR CONCLUSION CANNOT BE DRAWN. SINCE THE MAINTENANCE DATE HAS TO BE CARRIED OUT IN FEBRUARY 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. ROOT CAUSE CANNOT BE FINALLY CONCLUDED. THEREFORE THE ROOT CAUSE SPECIFIC RISK CANNOT BE IDENTIFIED. THE POTENTIAL RISK DETERMINED DURING INITIAL VIGILANCE EVALUATION REMAINS VALID. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.