MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE INVESTIGATION REVEALED MULTIPLE DEVIATIONS ON THE PRODUCT: TOOL COUPLING IS JAMMED. LOUD RUNNING NOISES DURING TEST RUN. BALL BEARINGS ARE JAMMED. INTERIOR SHOWS RESIDUES AND CORROSION. DEVICE HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE ACCORDING TO PROCEDURES: SEVERITY WAS 3(5) AND PROBABILITY 1(5). CONCLUSION AND PREVENTIVE MEASURES: THE FAILURE COMPLAINT BY THE CUSTOMER COULD BE CONFIRMED. THE DRILL IS STUCK INTO THE HANDPIECE DUE TO RESIDUES AND WEAR OF THE TOOL COUPLING. THE WHOLE INTERIOR SHOWS RESIDUES AND CORROSION AS WELL. THE INTERIOR IS COMPLETELY DRY AND SHOWS NO SIGN OF PROPER OILING. THE BALL BEARINGS ARE HEAVILY WORN OUT WHICH LED TO LOUD RUNNING NOISES. THE PRODUCT WAS PRODUCED IN 2016, SINCE DELIVERY THE HANDPIECE HAS NOT BEEN SERVICED/MAINTAINED. PLEASE DRAW THE CUSTOMER'S ATTENTION TO THE MAINTENANCE AND INSPECTION INSTRUCTIONS IN THE INSTRUCTIONS FOR USE (IFU). TO ENSURE RELIABLE OPERATION, THE PRODUCT MUST BE MAINTAINED AT LEAST ONCE A YEAR. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT GD450M - MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE MICRO-LINE OVERHEAT AND IMPOSSIBLE TO REMOVE THE DRILL. PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(6).

Additional Manufacturer Narrative

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