BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 4232436 · Received November 6, 2014

    Report

    Report Number
    2520274-2014-14528
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO (B)(4). CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT MANUFACTURING FACILITY. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS SEP 9, 2000. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS OBSERVED THAT THE DEVICE MADE AN UNUSUAL NOISE. IT WAS DETERMINED THAT THE NOISE WAS MOST LIKELY DUE FROM VARIOUS WORN COMPONENTS FROM NORMAL WEAROUT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE HANDLE ON THE QUICK COUPLING DEVICE WAS OUT OF ALIGNMENT WITH THE SMALL BATTERY DRIVE DEVICE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS THE ACTUAL DEVICES WERE USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    715877 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 00359

    Patients

    Seq Age Sex Outcome Treatment
    1 QUICK COUPLING DEVICE