BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH WIRE CUTTER STRAIGHT 16 CM TC

    MDR report key: 6105772 · Received November 16, 2016

    Report

    Report Number
    0001032347-2016-00677
    Event Type
    Injury
    Date Received
    November 16, 2016
    Report Date
    October 20, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. A VISUAL INSPECTION REVEALED MODERATE SIGNS OF WEAR INCLUDING MINOR SCRATCHES ALONG THE LENGTH OF THE INSTRUMENT AND A FRACTURE AT THE VERY TIP OF ONE OF THE CUTTING BLADES; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED AT THE TIP. THE NON-CONFORMANCE DATABASE WAS REVIEWED IN THE EVALUATION AND NO NON-CONFORMANCES WERE FOUND. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE DOCTOR CUT THE WIRE ON AN ARCH BAR, HE NOTICED A TINY PIECE OF THE TIP WAS BROKEN OFF. IT IS REPORTED IT WOULD NOT CUT PROPERLY ON THE FIRST AND SECOND USE. IT IS REPORTED, HOWEVER NOT CONFIRMED, THAT SUCTION WAS USED TO REMOVE THE TIP FROM THE PATIENT. IT IS REPORTED THAT THERE WAS NO DELAY AND THE DOCTOR DOES NOT CONSIDER THIS EVENT TO BE A PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756481 SMITH WIRE CUTTER STRAIGHT 16 CM TC WIRE CUTTER HXZ BIOMET MICROFIXATION N/A 520068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention