BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY CASING FOR POWER DRIVE

    MDR report key: 3871744 · Received June 13, 2014

    Report

    Report Number
    8030965-2014-10314
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION WITH AN UNSPECIFIED MALFUNCTION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. AN ASSESSMENT WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MISSING COMPONENTS. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING. 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 DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BATTERY CASING FOR POWER DRIVE DEVICE HAD AN UNSPECIFIED MALFUNCTION. IT WAS UNKNOWN IF THERE WERE ANY DELAYS TO THE SCHEDULED SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF THE EVENT WAS UNKNOWN; HOWEVER, THE REPORTER STATED THAT THE EVENT WAS DISCOVERED ON (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
    351029 BATTERY CASING FOR POWER DRIVE BATTERY, REPLACEMENT, RECHARGEABLE MOQ SYNTHES OBERDORF 3764604

    Patients

    Seq Age Sex Outcome Treatment
    1