BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4893028 · Received July 6, 2015

    Report

    Report Number
    1719045-2015-10432
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Report Date
    June 26, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE ASSOCIATED SUBJECT DEVICE LOT NUMBERS 004572/001987/5754027. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(4) 2012 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(4) 2015 AND REPORTED THE DEVICE IS INOPERABLE, WILL NOT ROTATE. THE PREVIOUS SERVICE CONDITIONS OF MOTOR FAILURE ARE RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE, WILL NOT ROTATE. THE MANUFACTURE DATE OF THIS ITEM IS 8-APR-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS CONFIRMED. A SERVICE AND REPAIR EVALUATION WAS ALSO PERFORMED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE DEVICE SOUNDED LIKE IT WAS RUNNING BUT THE BIT WOULD NOT TURN. THE REPAIR TECHNICIAN REPORTED THE MOTOR WAS RUNNING LOUD AND SLOW, AND RUNNING INCONSISTENTLY. ¿ MOTOR FAILURE¿ IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CIRCUIT BOARD, MOTOR, MEMBRANE SWITCH/FLEX CIRCUIT, AND ALL APPLICABLE COMPONENTS. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON (B)(4) 2015. THE EVALUATION WAS CONFIRMED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER DOES NOT TURN BUT SOUNDS LIKE IT IS RUNNING. THE REPORTED ISSUE WAS DISCOVERED DURING ROUTINE TESTING AND WAS INITIALLY DETERMINED TO BE NON-REPORTABLE. UPON THE SERVICE EVALUATION IT WAS DISCOVERED THAT THE DEVICE MOTOR WAS RUNNING LOUD AND SLOW, AND RUNNING INCONSISTENTLY. THE ISSUE WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE AT THAT TIME. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435175 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 004572 OLD LOT 5754027

    Patients

    Seq Age Sex Outcome Treatment
    1