BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR TIP RINGLOC INSERTER

    MDR report key: 3170259 · Received June 14, 2013

    Report

    Report Number
    0001825034-2013-01958
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 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
    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 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 PRECAUTIONS IT STATES, "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT."

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EVALUATION INDICATED THE LIKELY ROOT CAUSES TO BE EITHER THE HANDLE INSERTER NOT FULLY SEATED BEFORE IMPACTION OR IMPACTED AT AN INCORRECT ANGLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON UTILIZED A STRAIGHT INSERTER TO IMPACT THE SHELL. WHILE THE SURGEON WAS IMPACTING, THE TIP OF THE INSERTER HANDLE FRACTURED IN THE THREAD OF THE CUP. AS A RESULT, THE FRACTURED TIP REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270818 MODULAR TIP RINGLOC INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A RDWO30804

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S