BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3801867 · Received May 9, 2014

    Report

    Report Number
    2520274-2014-11367
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 17, 2014
    Manufacturer
    NI
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE FACILITY WAS UNKNOWN. (B)(6). THE DATE OF MANUFACTURE WAS UNKNOWN. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT REVEALED THAT THE COUPLING HEAD WAS DAMAGED AND THE DEVICE WOULD NOT ACCEPT ATTACHMENTS. THEREFORE, THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL USE OVER TIME. 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 FROM CANADA THAT DURING A HALLUX VALGUS CORRECTION SURGERY THE SMALL BATTERY DRIVE DEVICE WAS NOT WORKING. THERE A REPORTED DELAY OF TEN MINUTES TO THE PLANNED SURGICAL PROCEDURE AS A RESULT. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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
    281574 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE NI 004909

    Patients

    Seq Age Sex Outcome Treatment
    1