BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ATTACHMENT-MEDIUM FOR PEN DRIVE

    MDR report key: 3578235 · Received January 16, 2014

    Report

    Report Number
    8030965-2014-00133
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Report Date
    December 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODES: DZI, ERL, HBE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SERVICE HISTORY OF THE PAST SIX MONTHS WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS 9-SEP-2008. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    FACILITY REPORTED TO ANSPACH SERVICE AND REPAIR: THE BURR ATTACHMENT-MEDIUM FOR PEN DRIVE IS GETTING TOO HOT; THE DRILL BITS ARE STICKING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43397 BURR ATTACHMENT-MEDIUM FOR PEN DRIVE HWE SYNTHES GMBH 1911887/5872481

    Patients

    Seq Age Sex Outcome Treatment
    1