BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4289024 · Received December 2, 2014

    Report

    Report Number
    1719045-2014-10647
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Report Date
    November 5, 2014
    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

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE DEVICE STOPPED WORKING. THE REPAIR TECHNICIAN REPORTED THE MOTOR WAS VERY LOUD, THE CONTACT PLATE WAS CRACKED, THE DEVICE WAS STICKING, AND THERE WERE A LOT OF DEPOSITS INSIDE THE DEVICE. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN.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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. SERVICE HISTORY REVIEW: LOT #002789/6160390 A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS 12-JUN-2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 05.000.008, HAND PIECE FOR BATTERY POWERED DRIVER, LOT 6160390). THE CUSTOMER REPORTED THE DEVICE STOPPED WORKING. AS PREVIOUSLY REPORTED DURING THE SERVICE AND REPAIR EVALUATION, THE REPAIR TECHNICIAN REPORTED THE MOTOR WAS VERY LOUD, THE CONTACT PLATE WAS CRACKED, THE DEVICE WAS STICKING, AND THERE WERE A LOT OF DEPOSITS INSIDE THE DEVICE. THE DEVICE WAS NOT REPAIRABLE. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE SUBJECT DEVICE WAS FORWARDED TO THE SYNTHES COMPLAINT HANDLING UNIT (CHU) FOR ADDITIONAL INVESTIGATION. THE SERVICE AND REPAIR EVALUATION WAS CONFIRMED. AN INVESTIGATION AT THE CHU INDICATED THAT THE DEVICE WAS MANUFACTURED TO AN OLD DESIGN THAT HAS SINCE BEEN ADDRESSED, AND THAT THE DEVICE HAS NOT BEEN SERVICED SINCE ITS MANUFACTURE DATE (JUN 12, 2009). THIS COMPLAINT IS 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 SERVICE AND REPAIR DEPARTMENT DOCUMENTED THE HAND PIECE FOR BATTERY POWERED DRIVER QUANTITY 2 STOPPED WORKING DURING ROUTINE TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WILL MADE AVAILABLE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777240 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6160390

    Patients

    Seq Age Sex Outcome Treatment
    1