BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSORB LS 1.3MM 3 PIN KIT

    MDR report key: 5794724 · Received July 14, 2016

    Report

    Report Number
    0001825034-2016-02580
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 15, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    OVZ
    PMA / PMN Number
    PK140625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 4 STATES, ¿CORRECT HANDLING OF IMPLANTS IS EXTREMELY IMPORTANT. DO NOT NOTCH OR BEND IMPLANTS. NOTCHES OR SCRATCHES PUT IN THE IMPLANT DURING THE COURSE OF SURGERY MAY CONTRIBUTE TO BREAKAGE. INTRAOPERATIVE FRACTURE OF DEVICES CAN OCCUR IF EXCESSIVE FORCE (TORQUE) IS APPLIED WHILE SEATING.¿ PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    DURING AN ACETABULAR FRACTURE FIXATION PROCEDURE, TWO PINS FRACTURED. NO PATIENT INJURY OR DELAY WAS REPORTED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447198 ORTHOSORB LS 1.3MM 3 PIN KIT PIN, FIXATION OVZ BIOMET TRAUMA N/A 172210

    Patients

    Seq Age Sex Outcome Treatment
    1