BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT TRAY # 1 A3 NAIL

    MDR report key: 5319945 · Received December 22, 2015

    Report

    Report Number
    0008031020-2015-00611
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K112982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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 WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    PARTICLES HAVE BEEN OBSERVED IN THE BASE OF THE TRAYS (BRACKET COATING); SEVERAL BRACKETS ARE BENT OR LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845657 INSTRUMENT TRAY # 1 A3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other