BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ATTACHMENT-MEDIUM FOR PEN DRIVE

    MDR report key: 3014841 · Received March 21, 2013

    Report

    Report Number
    8030965-2013-00937
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: DZI, ERL, HBE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM WAS CONFIRMED. THIS CONDITION WAS LIKELY DUE TO NORMAL COMPONENT WEAR FROM USE OVER TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING A MASTIODECTOMY PROCEDURE, THE MEDIUM ATTACHMENT MADE NOISE. THE DURATION OF THE PROCEDURE WAS MORE THAN DOUBLED DUE TO THE SLOW PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117610 BURR ATTACHMENT-MEDIUM FOR PEN DRIVE HWE SYNTHES GMBH 3517753

    Patients

    Seq Age Sex Outcome Treatment
    1