BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR BREAKAWAY SCREW 1.8X18MM, STERILE

    MDR report key: 5328891 · Received December 28, 2015

    Report

    Report Number
    0008031020-2015-00703
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    January 20, 2014
    Report Date
    January 23, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) 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., MORRISVILLE PA AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF 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

    SCREW DID NOT SNAP OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853386 COMPR BREAKAWAY SCREW 1.8X18MM, STERILE IMPLANT HWC STRYKER GMBH X0470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other