BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE

    MDR report key: 6833735 · Received August 31, 2017

    Report

    Report Number
    9615128-2017-00002
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    February 22, 2013
    Report Date
    March 22, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HRS
    PMA / PMN Number
    K102597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PLATE IS IMPLANTED, IT WAS NOT AVAILABLE FOR INSPECTION. ALTHOUGH THE SCREW DID NOT LOCK TO PLATE, FRACTURE REDUCTION AND THE END RESULT OF THE IMPLANTATION WAS SATISFACTORY. EXAMINATION OF PRODUCTION RECORDS OF THE INVOLVED PLATE DID NOT REVEAL A DEVIATION THAT MAY HAVE CONTRIBUTED TO THE REPORTED CASE. TESTING OF ADDITIONAL PLATES FROM THE SAME LOT OF THE INVOLVED PLATE AS WELL AS FROM DIFFERENT PRODUCTION LOTS INDICATED THAT UPON APPLICATION OF EXCESSIVE FORCE, SCREW SPINNING MAY OCCUR AT ONE OF THE SCREW HOLES AT PLATE' PROXIMAL PORTION. AS INDICATED IN THE IFU FOR THE SYSTEM, APPLICATION OF HIGH TORQUE DURING SCREW TIGHTENING SHOULD BE AVOIDED, AS EXCESSIVE FORCE MAY DAMAGE THE BONE AND/OR IMPLANT. THE REPORT IS SUBMITTED FOLLOWING AN FDA INSPECTION AT THE MANUFACTURER FACILITY. DEVICE IS STILL IMPLANTED.

    Description of Event or Problem · 1

    A SCREW DID NOT LOCK TO THE PLATE. AS GOOD FRACTURE REDUCTION WAS ACHIEVED, AND THE IMPLANT WAS STABLE, THE DEVICE REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615173 PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE BONE PLATE HRS CARBOFIX ORTHOPEDICS LTD. PLT00601

    Patients

    Seq Age Sex Outcome Treatment
    1