BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 12V BATTERY

    MDR report key: 3981785 · Received August 5, 2014

    Report

    Report Number
    3009450871-2014-10311
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. SERVICE HISTORY REVIEW OF THE DEVICE HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE FAILURE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE SERVICE HISTORY REVIEW SHOWS NO PREVIOUS SERVICE CONDITIONS RELEVANT TO THE CURRENT COMPLAINT ISSUE. AFTER PRE-REPAIR DIAGNOSTIC ASSESSMENT, THE DEVICE HAS NOT BEEN SERVICED. THE SERVICE TECHNICIAN NOTED THE ACTION TAKEN AS EXCHANGE, REPLACEMENT. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FAILURE CODE AS WORN-OUT. THE SERVICE TECHNICIAN IDENTIFIED THE PROBABLE ROOT CAUSE AS NORMAL WEAR. THE DEVICE WAS RETURNED TO THE CUSTOMER. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS DEVICE FAILURE, THE BATTERY DOES NOT FUNCTION. BATTERY LOSES POWER FASTER THAN NORMAL. THIS REPORT IS FOR 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458499 SMALL BATTERY DRIVE 12V BATTERY INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS D111206

    Patients

    Seq Age Sex Outcome Treatment
    1