BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLOTTED FIXATION BOLT WRENCH RINGFIX

    MDR report key: 5316710 · Received December 21, 2015

    Report

    Report Number
    0008031020-2015-00559
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH GUIDANCE FROM THE POLICY BRANCH OF THE FDA, REPORTED BY STRYKER GMBH, (B)(6) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) HOWMEDICA OSTEONICS CORP.¿S PURCHASED CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    TABS OF WRENCHES ARE BROKEN OFF - SBI MARKETING HAS NOTIFIED FIELD OF THE SLOTTED FIXATION BOLT. THIS BOLT WILL ELIMINATE THE NEED FOR THE WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841861 SLOTTED FIXATION BOLT WRENCH RINGFIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH M28996

    Patients

    Seq Age Sex Outcome Treatment
    1 Other