BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3140236 · Received May 31, 2013

    Report

    Report Number
    8030965-2013-02564
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A REVIEW OF THE SERVICE HISTORY FOR THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS PERFORMED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE SOURCE OF THE MANUFACTURE DATE IS THE DEVICE HISTORY RECORD REVIEW. (B)(6). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A HAND SURGICAL PROCEDURE (TYPE UNKNOWN) ON (B)(6) 2013, THE SMALL BATTERY DRIVE WAS NOT GETTING ENOUGH TORQUE. THE BATTERY DRIVE WOULD LOSE TORQUE WHEN ENGAGING WITH THE BONE. IT WAS ALSO REPORTED THE SURGEON WAS ABLE TO COMPLETE THE COUNTER-SINK NECESSARY TO COMPLETE THE PROCEDURE AFTER AN ESTIMATED FIVE MINUTE DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR A SMALL BATTERY DRIVE. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242478 SMALL BATTERY DRIVE HWE SYNTHES GMBH 2601

    Patients

    Seq Age Sex Outcome Treatment
    1