BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4631113 · Received March 25, 2015

    Report

    Report Number
    1719045-2015-10189
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Report Date
    March 10, 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A SERVICE HISTORY RECORD REVIEW WAS REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A SERVICE HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: SERVICE HISTORY REVIEW: LOT #005466/003820 A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 21-AUG-2014 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 10-MAR-2015 AND REPORTED THE REVERSE WORKS INTERMITTENTLY MAKING THE DEVICE INOPERABLE. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE REVERSE WORKS INTERMITTENTLY MAKING THE DEVICE INOPERABLE. THE MANUFACTURE DATE OF THIS ITEM IS 8-OCT-2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS CONFIRMED. THE CUSTOMER REPORTED THE REVERSE SPEED WAS WORKING INTERMITTENTLY. THE REPAIR TECHNICIAN REPORTED THE MEMBRANE SWITCH WAS FAULTY. ELECTRONIC CONTROL DAMAGED IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: MOTOR/GEARING BARRIER, HOUSING BARRIER, MEMBRANE SWITCH & FLEX CIRCUIT. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON 2-APR-2015. 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.

    Additional Manufacturer Narrative · 1

    DATE RCVD BY MFR: DATE IS 03/30/2015. 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

    SERVICE AND REPAIR REPORTED THAT PART 05.000.008 REVERSE SPEED WORKS ONLY INTERMITTENLY. THIS WAS DISCOVERED PRE-OP DURING ROUTINE TESTING.. NO IMPACT OR INVOLVEMENT TO CASE OR PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198447 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 003820

    Patients

    Seq Age Sex Outcome Treatment
    1