BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL NAIL 8X280 MM

    MDR report key: 2090626 · Received April 19, 2011

    Report

    Report Number
    9610622-2011-00170
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K011529
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED ITEMS WERE ASSEMBLED WITH A SAMPLE NAIL HOLDING SCREW: IT WAS POSSIBLE TO TWIST THE NAIL IN CLOCKWISE DIRECTION TO THE POINT WHERE THE TOOTH OF THE NAIL ADAPTER CONTACTED THE TOOTH OF THE NAIL CONNECTION. IN THIS MODE THE NAIL HOLES ARE NO LONGER IN COMPARISON WITH THE TARGETING ARM'S GUIDING HOLES AND A SAMPLE DRILL HIT THE SAME DAMAGED AREAS OF THE LOWER AND MIDDLE PROXIMAL NAIL HOLES. AFTER THAT, THE RETURNED TARGETING ARM WAS TESTED WITH A SAMPLE NAIL AND SAMPLE INSTRUMENTS. ALL NAIL HOLES COULD BE PASSED INSIDE SPECS. REVIEW OF DEVICE HISTORY RECORD - A REVIEW OF THE INSPECTION RECORDS FOR THE HUMERUS NAIL REVEALED NO DISCREPANCIES. EVAL REVEALED THE HUMERUS NAIL TO BE THE PRIMARY PRODUCT. DEVIATIONS IN THE MFG DOCUMENTS WERE NOT FOUND. THE REPORTED ISSUE COULD BE REPRODUCED. NO MFG FAULTS FOUND. EVAL REVEALED THAT THE BROKEN AND DEFORMED NAIL CONNECTION IS LINKED TO TOO HIGH TORSION MOMENT DURING ASSEMBLING (USER RELATED).

    Description of Event or Problem · 1

    THE NURSE REPORTS VIA OUR SALES REP, THAT DURING INSERTION OF THE NAIL A PART OF THE NAIL IN THE CONNECTING AREA TO THE TARGET DEVICE BROKE OFF. SHE FURTHER REPORTS THAT WITH THE SAME TARGET DEVICE, A NAIL WITH DIFFERENT LENGTH WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL NAIL 8X280 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K477252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other