BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4819408 · Received June 4, 2015

    Report

    Report Number
    1719045-2015-10356
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    May 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODE: GXL. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT 004558/003856: A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON MARCH 07, 2013 DUE TO MOTOR FAILURE, (B)(6) 2012 FOR HOUSING DAMAGE AND (B)(4) 2014 FOR PREVENTATIVE MAINTENANCE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(4) 2015 AND REPORTED THE DEVICE IS INOPERABLE. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE. THE MANUFACTURE DATE OF THIS ITEM IS JANUARY 27, 2011. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS CONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE REQUIRED SERVICE. THE REPAIR TECHNICIAN REPORTED THE REVERSE SPEED WAS NOT WORKING. ELECTRONIC CONTROL DAMAGED 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 THAT FOR ONE HAND PIECE FOR BATTERY POWERED DRIVER THE REVERSE SPEED WAS NOT WORKING. FOR THREE OTHERS THE MOTOR WAS RUNNING INTERMITTENTLY. THERE IS NO PATIENT INVOLVED. THE ISSUE DOES NOT INVOLVE A SURGERY. IT WAS DISCOVERED DURING EVALUATION AFTER THE DEVICES WERE RETURNED TO THE MANUFACTURER. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362707 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 003856

    Patients

    Seq Age Sex Outcome Treatment
    1