BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM HAND PLATE BENDER

    MDR report key: 6734362 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-05142
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 6, 2017
    Report Date
    May 15, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED DEVICES ARE ONE 2.0MM HAND PLATE BENDER, ITEM 231220100 LOT 352531 AND ONE 2.0MM HAND PLATE BENDER END, ITEM 231220101 LOT 352541. VISUAL ANALYSIS CONFIRMS BOTH DEVICES TO BE FRACTURED AT THE TIP. THIS ANALYSIS ALSO IDENTIFIES COSMETIC DAMAGE TO THE 2.0MM HAND PLATE BENDER END, BEGINNING APPROXIMATELY 1" AFTER THE BEND OF THE DEVICE, AND CONTINUING DISTALLY ALONG THE SHAFT APPROXIMATELY HALFWAY TO THE FRACTURED TIP. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE-HXP. CONCOMITANT PRODUCTS: PLATE BENDER CATALOG#:231220101 LOT#:352541. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05143.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADIAL PROCEDURE, THE TIPS OF THE BENDERS FRACTURED AND FELL INTO THE PATIENT. ALL FRACTURED PIECES WERE SUCCESSFULLY RETRIEVED. NO IMPACT TO THE PATIENT IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512848 2.0MM HAND PLATE BENDER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET TRAUMA N/A 352531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other REFERENCE H10