BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4661528 · Received April 6, 2015

    Report

    Report Number
    1719045-2015-10215
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Report Date
    April 3, 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT 002289/5882247: A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(4) 2012 AND (B)(4) 2013 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2015 AND REPORTED THE DEVICE IS INOPERABLE. THE PREVIOUS SERVICE CONDITIONS OF MOTOR FAILURE ARE RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE. THE SERVICE HISTORY EVALUATION IS CONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE WAS NOT FUNCTIONING PROPERLY. THE REPAIR TECHNICIAN REPORTED THE MOTOR WAS RUNNING SLOW, AND THE REVERSE SPEED WAS NOT WORKING. 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 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

    IT WAS REPORTED THE HAND PIECE FOR BATTERY POWERED DRIVER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT OR CASE IMPACT AND THAT THE ISSUE WAS FOUND OUTSIDE OF THE OPERATING ROOM. IT WAS NOTED AFTER THE DEVICE WAS RECEIVED BY THE MANUFACTURER THAT THE MOTOR WAS RUNNING SLOW, AND THE REVERSE SPEED WAS NOT WORKING. MOTOR FAILURE IS THE REASON FOR REPAIR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227032 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 5882247

    Patients

    Seq Age Sex Outcome Treatment
    1