BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3912232 · Received July 3, 2014

    Report

    Report Number
    8030965-2014-10352
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 SMALL BATTERY DRIVE DEVICE WAS MAKING NOISE AND NOT WORKING PROPERLY. THE REPORTED EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE IDENTICAL WAS AVAILABLE. THERE WERE NO REPORTED INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS CLARIFIED THE EVENT OCCURRED IN (B)(6) 2014. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391657 SMALL BATTERY DRIVE INSTR.SURGICAL. ORTHOPEDIC.AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF 001638

    Patients

    Seq Age Sex Outcome Treatment
    1