BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4544536 · Received February 25, 2015

    Report

    Report Number
    1719045-2015-10127
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Report Date
    February 13, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT 005381/5880017/002265 FOR THE PAST THREE YEARS. 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 8-OCT-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A SERVICE EVALUATION WAS ALSO PERFORMED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE DRILL COVER HEATED UP, AND THE MOTOR WAS RUNNING CONTINUOUSLY. THE REPAIR TECHNICIAN REPORTED THE MOTOR WAS RUNNING SLOW. 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 ON (B)(6) 2015. 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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: GXL. DEVICE INSTRUMENT AND IS AN IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE HISTORY REVIEW HAS BEEN REQUESTED. 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 BY THE SERVICE AND REPAIR DEPARTMENT THAT THE HAND PIECE FOR THE BATTER POWERED DRIVER DRILL COVER HEATS UP AND THE MOTOR AUTOMATICALLY RUNS AND WON'T STOP WHEN PLUGGED INTO THE BATTERY. THIS WAS DISCOVERED WHILE PREPPING FOR SURGERY. THERE WERE NO REPORTS OF HARM TO THE PATIENT OR OF ANY SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133077 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 5880017

    Patients

    Seq Age Sex Outcome Treatment
    1