BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRIST CARPAL BALL IMPLANT, NEUTRAL, SMALL

    MDR report key: 5328804 · Received December 28, 2015

    Report

    Report Number
    0008031020-2015-00652
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    JWJ
    PMA / PMN Number
    K021859
    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)(4), 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

    HAIR FOUND INSIDE STERILE PACKAGING.

    Description of Event or Problem · 1

    HAIR FOUND INSIDE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853535 WRIST CARPAL BALL IMPLANT, NEUTRAL, SMALL PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED JWJ STRYKER GMBH 9614-L01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other