ACCULAN 4 DRILL AND REAMER

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT GA330 - ACCULAN (B)(4) DRILL AND REAMER. ACCORDING TO THE COMPLAINT DESCRIPTION, THE MOTOR FROM THE MEDICAL DEVICE HEATS. THE PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE 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.

Additional Manufacturer Narrative

INVESTIGATION: THIS PRODUCT WAS FORWARDED TO THE AESCULAP TECHNICAL SERVICES (ATS) DEPARTMENT. DURING THE FUNCTION TEST THE MACHINE STOPS RUNNING UNDER LOAD. AFTER DISASSEMBLING THE MACHINE THERE ARE A LOT OF RESIDUES IN THE INNER SPACE. THE INSIDE OF THE STATOR IS DEFORMED/ BLOATED, THIS HAD THE EFFECT THAT THE INNER ROTOR HAS BEEN DAMAGED AS WELL. DEVICE HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS ONE MORE COMPLAINT WITH THIS BATCH IN THE SYSTEM. HOWEVER, THIS SHOWS A DIFFERENT ERROR PATTERN. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE; SEVERITY WAS 3(5) AND PROBABILITY 1(5). EXPLANATION AND RATIONALE: THE FAILURE COMPLAINED BY THE CUSTOMER COULD NOT BE REPRODUCED. NO HEAT WAS DETECTED DURING THE RUNNING TEST. THE MACHINE STOPS RUNNING UNDER LOAD, BECAUSE OF AN INNER SHAPE DEVIATION OF THE STATOR. THIS RESULTED IN DAMAGE TO THE ROTOR, THE ROTOR COULD NO LONGER MOVE FREELY IN THE STATOR. IT IS POSSIBLE THAT UNDER CERTAIN CIRCUMSTANCES THIS COULD HAVE CAUSED HEATING. THE INNER SPACE OF THE STATOR HAS STRONG RESIDUES, THERE ARE NO INDICATIONS WHERE THE RESIDUES ARE FROM. THE MAINTENANCE DATE OF THE MACHINE IS EXCEEDED BY 14 MONTHS. SINCE THE MAINTENANCE DATE PRESCRIBED IN THE INSTRUCTIONS FOR USE (IFU) WAS NOT CARRIED OUT, THE MACHINE COULD NOT BESERVICED. THE COMPONENTS AND RESIDUES TO WEAR AND TEAR COULD BE LED INTO THE DEFECT OF THE MACHINE. THE PRODUCT IS OUT OF WARRANTY. CONCLUSION AND PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.