BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD CRANIOTOME, BLACK MAX

    MDR report key: 3241341 · Received July 22, 2013

    Report

    Report Number
    1045834-2013-03605
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE FAILED FUNCTIONAL TESTING AS IT WOULD NOT LOCK ONTO A MOTOR DEVICE PROPERLY. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO USAGE/WEAR OVER TIME. 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 DURING A CRANIOTOMY SURGERY AN ATTACHMENT DEVICE WAS "NOT WORKING". THE PLANNED SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AS A SPARE IDENTICAL DEVICE WAS AVAILABLE FOR USE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT THE REPORTER CLARIFIED THAT THE EVENT OCCURRED IN (B)(6) 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
    340042 STANDARD CRANIOTOME, BLACK MAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1