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Patient 1
ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00014 ((B)(4) GD675). MANUFACTURING SITE EVALUATION: WE RECEIVED A COMPLAINT ABOUT A GB757R - HI-LINE XS ANGLED HANDPIECE II AND A GD675 - MICROSPEED UNI XS HIGHSPEED MOTOR. WE DID RECEIVE THE DEVICES IN DECONTAMINATED CONDITION FOR INVESTIGATION. INVESTIGATION: OPTICALLY, THE DEVICES ARE IN A USED CONDITION. THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICE (ATS): THE HANDPIECE WAS DISTRIBUTED IN APRIL 2014 AND SHOWS A MAINTENANCE DUE DATE OF 2015- 06. HOWEVER, REPAIRS CAN BE FOUND IN THE DATABASE WHICH WERE EXECUTED AT B.BRAUN SHEFFIELD. ACCORDING TO THE DATABASE, THE LAST REPAIR TOOK PLACE IN NOVEMBER 2019. THE FUNCTIONAL CHECK REVEALED THAT IT IS NOT POSSIBLE TO CLAMP A TOOL IN THE HANDPIECE. HOWEVER, A RUNNING TEST WITHOUT A TOOL COULD BE EXECUTED. THE HANDPIECE BECAME HOT WITHIN A MINUTE (41 DEGREE). AFTER THE DISASSEMBLY OF THE SHAFT, THE BALL BEARINGS COULD BE CHECKED. STAINING AND CORROSION WAS DETECTED AT THE BALL BEARINGS. THESE RESIDUES LED TO A BLOCKING OF THE BALL BEARINGS AND THEREFORE MOST LIKELY TO THE MENTIONED HEATING AND THE IMPROPER TOOL CLAMPING. FURTHERMORE, RESIDUES CAN ALSO BE FOUND INSIDE THE TOOL HOLDER. BATCH HISTORY REVIEW: THE TRACEABILITY OF ARTICLES WITH BATCH MANAGEMENT REQUIREMENT IS GUARANTEED BY THE PRODUCTION ORDER NUMBER, WHICH CAN BE TRACED OVER THE PRODUCTION PERIOD AND THE CORRESPONDING CUSTOMER (BACKTRACK). IN ADDITION, THE RAW MATERIALS, SEMI-FINISHED PARTS, ETC. USED FOR THE ORDER ARE DOCUMENTED IN THE MANUFACTURING HISTORY RECORDS (DHR - DEVICE HISTORY RECORDS). THIS ENSURES THE TRACEABILITY OF THE INTERNAL SUPPLY AND PRODUCTION CHAIN. INTERNAL TRACEABILITY IS THUS GUARANTEED. CONCLUSION AND ROOT CAUSE: THE FAILURE IS MOST PROBABLY REPROCESSING RELATED. RATIONALE: REFER TO INVESTIGATION. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.