BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRO FEM CONNECTING BOLT

    MDR report key: 3121544 · Received May 21, 2013

    Report

    Report Number
    0001825034-2013-01579
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION WAS PERFORMED. THE ROOT CAUSE WAS ATTRIBUTED TO IMPROPER SURGICAL TECHNIQUE.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER CARE AND HANDLING OF INSTRUMENTS IS STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT PHOENIX: RETROGRADE FEMORAL NAIL PROCEDURE ON (B)(6) 2013. WHILE THE SURGEON WAS UTILIZING THE CONNECTING BOLT THE TIP FRACTURED AND FELL INTO THE WOUND AND WAS RETRIEVED. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224712 RETRO FEM CONNECTING BOLT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 184910

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R