BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STR RINGLOC+ BTN LTCH INSERTER

    MDR report key: 3150684 · Received June 6, 2013

    Report

    Report Number
    0001825034-2013-01857
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 9, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. THERE WAS EVIDENCE OF LATERAL IMPACTION AND POSSIBLE USE AS A LEVER. THE SURGICAL TECHNIQUE STATES, "DO NOT LEVER ON THE INSERTER HANDLE TO REPOSITION THE CUP AS THIS MAY DAMAGE THE THREADS."

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE ASSOCIATED PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "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." EVALUATION OF THE RETURNED DEVICE FOUND EVIDENCE INDENTATION MARKS/SCRATCHES TOWARD THE THREADED END ON THE INSERTER. THIS COULD BE FROM IMPACTION TO REPOSITION THE CUP AND COULD CAUSE THE THREADS TO BREAK OFF. THE SURGICAL TECHNIQUE WARNS THAT THE THREADS MAY BECOME DAMAGED WHEN THE INSERTER IS USED TO LEVER OR REPOSITION THE CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP ARTHROPLASTY PROCEDURE UTILIZING AN ACETABULAR CUP INSERTER ON (B)(6) 2013. DURING THE PROCEDURE, THE TIP OF THE INSERTER FRACTURED IN THE ACETABULAR CUP UPON INSERTION. THE TIP OF THE INSERTER WAS RETAINED BY THE PATIENT AND THE ACETABULAR CUP WAS LEFT IN PLACE AS THE SURGEON ACHIEVED PROPER PLACEMENT OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250847 STR RINGLOC+ BTN LTCH INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 604010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S