BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSORB 1 PIN 50X1.3MM KIT

    MDR report key: 4141127 · Received October 3, 2014

    Report

    Report Number
    0001825034-2014-07966
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT IMPLANTED/EXPLANTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT FOOT THIRD DIGIT ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE SURGEON PUT IN THE K-WIRE AND WHEN THE ORTHOSORB PIN SLID IN, THE K-WIRE CAME UNDONE. ANOTHER ORTHOSORB PIN WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618490 ORTHOSORB 1 PIN 50X1.3MM KIT PIN, FIXATION OVZ BIOMET ORTHOPEDICS N/A 310584

    Patients

    Seq Age Sex Outcome Treatment
    1