BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.25CM ATTACHMENT, BM

    MDR report key: 3241348 · Received July 22, 2013

    Report

    Report Number
    1045834-2013-03604
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THE DEVICE HAD INTERNAL COMPONENTS MISSING AND DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO MISHANDLING AT THE CUSTOMER SITE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE RINGS INSIDE THE ATTACHMENT DEVICE WERE OFF". THE REPORTER STATED THE DEVICE "CAME DOWN WITH A REPAIR TAG". IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY.  IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE.  IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT THE REPORTER CLARIFIED THE EVENT OCCURRED IN 2013.  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
    340747 11.25CM ATTACHMENT, BM BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1