BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02825

    MDR report key: 3133049 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02825
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PUT K WIRES THROUGH COMPRESSION DEVICE, ONE WIRE BROKE OFF AND REMAINED STUCK IN COMPRESSION DEVICE. THIS ADDED ABOUT 15 MINUTES TO PROCEDURE TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY; HOWEVER, THE K WIRE IS STILL STUCK IN COMPRESSION DEVICE. THIS PART IS DAMAGED, BUT WILL BE RETURNED AS PER THE USUAL EVALUATION DEVICE RETURN METHOD, ALONG WITH REFERENCE TO THIS DEVICE LOG OR COMPLAINT. THIS REPORT IS FOR UNKNOWN PINS/WIRES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236157 HTY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR