BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 10052903 · Received May 13, 2020

    Report

    Report Number
    0001526350-2020-00448
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 25, 2020
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). -PRODUCT REVIEW OF THE ELECTRIC DERMATOME SERIAL NUMBER (B)(6) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON (B)(6) 2020 REVEALED THAT THE MOTOR¿S RPM WAS IN SPECIFICATION, HOWEVER THE MOTOR WAS, A LITTLE ERRATIC, AND THE CALIBRATION WAS OFF AT THE 0 READING. -REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON (B)(6) 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: SEMI-CIRCLE SHAFT BEARING: PN 06-0017-200-68 SPRING SEAL: PN 06-0018-103-82 BALL BEARING: PN 06-0018-103-81 VESPEL: PN 06-0018-105-35 THE DEVICE, SERIAL NUMBER (B)(6) WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. -REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -DEVICE IS USED FOR TREATMENT. -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. -NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. -THE EVENT IS CONFIRMED.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-0601002. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS SKIPPING, WOULD LIKE IT INSPECTED TO ENSURE IT'S IN GOOD WORKING ORDER, MALFUNCTION DURING SURGERY ON (B)(6) 2020, NO HARM, NO INTERVENTION, NO DELAY, NO VARIANCE, NO OTHER INFO. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514475 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 64581507

    Patients

    Seq Age Sex Outcome Treatment
    1 00882100600POWER SUPPLY, ELEC. DERMATOME2107CAAB| 00882100600POWER SUPPLY, ELEC. DERMATOME2107CAAB