BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFS PROV FIXATION PIN LONG STE

    MDR report key: 3706426 · Received March 27, 2014

    Report

    Report Number
    0001825034-2014-02240
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    February 25, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE MATERIAL ANALYSIS, IT WAS NOTED THE COMPONENT SHOWED EVIDENCE OF TORSIONAL OVERLOAD.

    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 THAT 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 AND PRECAUTIONS: "PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE NAIL, ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TIBIA FRACTURE PLATING PROCEDURE UTILIZING A FIXATION PIN ON (B)(6) 2014. DURING THE PROCEDURE, THE DISTAL END OF THE FIXATION PIN FRACTURED AND WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181326 SFS PROV FIXATION PIN LONG STE FIXATION, FASTENER LXH BIOMET ORTHOPEDICS N/A E88AA4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S