BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM

    MDR report key: 5183296 · Received October 28, 2015

    Report

    Report Number
    0008031020-2015-00440
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    JDW
    PMA / PMN Number
    K861766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM WAS ALLEGEDLY BROKEN DURING INSERTION COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A R&D/DESIGN RELATED ISSUE. THE FAILURE WAS CAUSED BY TOO HIGH TOLERANCES ON THE TIP OF THE PIN. AN NC AND CAPA HAVE BEEN OPEN TO ADDRESS THE RECURRING SITUATION OF THE SELF-DRILLING HALF PIN APEX Ø 3MM BREAKAGES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. DEVICE WAS LOST.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    APEX PIN BROKE ON INSERTION INTO TIBIA DURING OPERATION ON RIGHT LEG OF PATIENT.

    Description of Event or Problem · 1

    APEX PIN BROKE ON INSERTION INTO TIBIA DURING OPERATION ON RIGHT LEG OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713330 SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM PIN, FIXATION, THREADED JDW STRYKER GMBH F38950

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other