BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN DRIVER

    MDR report key: 5308548 · Received December 17, 2015

    Report

    Report Number
    0008031020-2015-00501
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    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. 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

    REP NOTICED THE PIN DRIVERS WERE BROKE AFTER SURGERY.

    Description of Event or Problem · 1

    REP NOTICED THE PIN DRIVERS WERE BROKE AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833492 PIN DRIVER PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 0918902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other