BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRO FEM CONNECTING BOLT

    MDR report key: 3772329 · Received April 25, 2014

    Report

    Report Number
    0001825034-2014-03129
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 27, 2014
    Report Date
    August 25, 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

    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. PRODUCT IS BEING RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RECEIVED. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03129 / 03130).

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE REVEALED THREADS OF THE INSTRUMENT WERE DAMAGED. EVALUATION OF DEVICE SUGGESTS THE INSTRUMENTS WERE LIKELY DAMAGED AFTER INITIAL DISTRIBUTION. ROOT CAUSE FOR THE REPORTED EVENT DETERMINED TO BE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A FIXED FEMORAL FRACTURE PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, WHILE THE SURGEON USED THE SLAP HAMMER, THE TARGETING DEVICE DISCONNECTED FROM THE NAIL. THE NAIL WAS ENGAGED SEVERAL TIMES WITH THE SAME RESULTS. AN ADDITIONAL CONNECTING BOLT WAS ATTEMPTED FOR USE WITH THE SAME RESULTS. SURGEON COMPLETED THE PROCEDURE MANUALLY. THIS CAUSED A DELAY OF GREATER THAN 30 MINUTES IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252629 RETRO FEM CONNECTING BOLT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 184960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R