BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.6CM TAPERED ATTACHMENT, BLACK MAX

    MDR report key: 3201982 · Received July 2, 2013

    Report

    Report Number
    1045834-2013-02638
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 10, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HSZ
    PMA / PMN Number
    K981465
    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 THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATES THIS WAS DUE TO IMPROPER HANDLING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE WOULD "NOT SPIN". 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.  NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED.  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
    302097 12.6CM TAPERED ATTACHMENT, BLACK MAX INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED-ATTACHMENT HSZ DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1