BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 8713558 · Received June 19, 2019

    Report

    Report Number
    0001526350-2019-00496
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    December 13, 2018
    Report Date
    June 19, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR AND PREVIOUS REPAIR REPORT REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER (B)(4) THREE TIMES AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(6) 2017 WHERE IT WAS REPORTED THAT THE DEVICE NEEDED PREVENTATIVE MAINTENANCE AND THE BEARINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL BEARINGS, DIE CAST LEVER, BALL PLUNGER, MOTOR, RECIPROCATING ARM, THICKNESS CONTROL SHAFT, CONTROL BAR, LEVER DIE CAST ALUMINUM, PLUG HARNESS ASSEMBLY, SEAL/STRAIN RELIEF, AND SWITCH WERE REPLACED. THIS IS NOT A RELATED ISSUE. ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE BROKE DOWN BEFORE SURGERY. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. PRODUCT REVIEW OF THE ELECTRIC DERMATOME BY FLEXTRONICS ON (B)(6) 2019 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE 0 SETTING AND SIDE TO SIDE 30 SETTING. THE MOTOR SPEED WAS ABOVE SPECIFICATIONS AND THE POWER CORD WAS DAMAGED. THE CONTROL BAR WAS DAMAGED AND THERE WERE SCREWS MISSING. THE CUSTOMER DID NOT RETURN A POWER SUPPLY FOR EVALUATION. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY FLEXTRONICS ON (B)(6) 2019 WHICH INCLUDED REPLACEMENT OF THE MOTOR, PLUG HARNESS ASSEMBLY, SEMI-CIRCLE SHAFT BEARINGS, SCREWS, FINE ADJUSTMENT CAMS, VESPEL BEARINGS, CONTROL BAR ASSEMBLY, SWITCH, AND NEEDLE BEARING. ELECTRIC DERMATOME, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. RMA NUMBER (B)(4). THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE IT IS UNKNOWN WHICH EXACT FAILURE FOUND WAS CAUSING THE UNIT TO NOT OPERATE PROPERLY FOR THE CUSTOMER. IT WAS FOUND DURING EVALUATION THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO AND SIDE TO SIDE 30 SETTINGS, THE MOTOR SPEED WAS ABOVE SPECIFICATION, THE POWER CORD AND CONTROL BAR WERE BOTH DAMAGED, AND THERE WERE MISSING SCREWS. ALL OF THOSE FAILURES FOUND COULD HAVE CONTRIBUTED TO THE CUSTOMER REPORTING THAT THE UNIT WAS NOT OPERATING PROPERLY BUT IT IS UNKNOWN WHAT EXACT FAILURE THE CUSTOMER WAS EXPERIENCING. THE UNIT WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE MOTOR, PLUG HARNESS ASSEMBLY, SEMI-CIRCLE SHAFT BEARINGS, SCREWS, FINE ADJUSTMENT CAMS, VESPEL BEARINGS, CONTROL BAR ASSEMBLY, SWITCH, AND NEEDLE BEARING WERE REPLACED AND THE UNIT WAS RE-CALIBRATED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DERMATOME DEFECT. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE POWER CORD WAS DAMAGED AND THAT THERE WERE MISSING SCREWS. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505975 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 61445641

    Patients

    Seq Age Sex Outcome Treatment
    1