BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 5231049 · Received November 17, 2015

    Report

    Report Number
    1719045-2015-10748
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Report Date
    October 30, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE MOTOR WAS DEAD. THE REPAIR TECHNICIAN REPORTED THE MOTOR WOULD NOT TURN. 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. THE EVALUATION WAS CONFIRMED.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSISIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: GXL. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: PART NO. 05.000.008 6030050, SERIAL/LOT NO: (B)(4): A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 25 JANUARY 2015 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2015 AND REPORTED THE DEVICE WAS INOPERABLE-RUNS CONTINUOUSLY IN REVERSE. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE BEING INOPERABLE-RUNS CONTINUOUSLY IN REVERSE. THE MANUFACTURE DATE OF THIS ITEM IS 19 NOVEMBER 2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    WHEN THE DEVICE WAS BEING EVALUATED BY THE MANUFACTURER, IT WAS NOTED THAT THE DEVICE HAD A DEAD MOTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR FOR A HAND PIECE FOR BATTERY POWERED DRIVER RUNS CONSTANTLY IN REVERSE WHEN A BATTERY IS ATTACHED. THIS WAS DISCOVERED PRE-OPERATIVELY, DURING TESTING. ANOTHER IN THE SET WAS AVAILABLE FOR USE TO COMPLETE THE SURGERIES. THERE WAS NO DELAY IN SURGERY AND NO HARM TO PATIENT. THIS OCCURRED BEFORE PATIENT WAS IN OPERATING ROOM (OR). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760695 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6030050

    Patients

    Seq Age Sex Outcome Treatment
    1