BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02868

    MDR report key: 3132984 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02868
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, A SURGEON WAS INSERTING A 2.7MM VARIABLE ANGLE LOCKING SCREW IN THE HEAD OF THE 2.7MM VARIABLE ANGLE FIBULA PLATE. THE SURGEON WAS INSERTING THE SCREW UNDER POWER AND THE SCREW RECESS BEGAN TO STRIP. THE SURGEON REMOVED THE SCREW THAT WAS STRIPPING, AND DISCARDED IT AND INSERTED A NEW SCREW BY HAND-TIGHTENING IT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THIS REPORT IS FOR AN UNKNOWN VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234947 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1