BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HU-FRIEDY

    MDR report key: 5183918 · Received October 28, 2015

    Report

    Report Number
    1416605-2015-00003
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    August 10, 2015
    Report Date
    October 16, 2015
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EIX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTENDED USE OF THE 678-101L ORTHODONTIC DISTAL END CUTTER IS TO CUT ORTHODONTIC WIRE AT THE DISTAL END OF THE ORAL CAVITY AND HOLD THE WIRE IN THE CUTTING BLADE WHILE THE JAWS ARE ENGAGED, UNTIL THE INSTRUMENT IS REMOVED FROM THE ORAL CAVITY. THE CUSTOMER STATED THE CUTTER INVOLVED IN THIS INCIDENT DID NOT HOLD THE WIRE DUE TO A LARGER GAP ON A PORTION OF THE CUTTING BLADE, WHICH CAUSED THE ORTHODONTIC WIRE TO EMBED INTO THE PATIENT'S CHEEK. THERE WAS AN INJURY REQUIRING THE PATIENT TO SEE AN ORAL SURGEON. THE CUSTOMER STATED THAT THERE SEEMED TO BE A LARGE "CURVE" CAUSING THE LACK OF WIRE-HOLDING ABILITY. THE INSTRUMENT WAS RETURNED TO HU-FRIEDY FOR EVALUATION. THE EVALUATION REVEALED THAT THE CUSTOMER'S OBSERVATION WAS CORRECT, AND THAT THE CUTTING SURFACES DID NOT MATE CORRECTLY. THEREFORE, THE WIRE DID NOT HOLD IN THE JAWS. THE CUTTING SURFACES NOT MATING PROPERLY WAS CAUSED BY IMPROPER SHARPENING TAKING PLACE DURING SERVICING OF THE INSTRUMENT, WHICH OCCURED AT HU-FRIEDY IN APRIL OF 2015. THIS MALFUNCTION WAS NOT PART OF THE ORIGINAL MANUFACTURING PROCESS, BUT A RESULT OF A SERVICING PROCESS ON LIMITED ITEMS. IN ADDITION, THE INSTRUMENT APPEARS TO BE HEAVILY USED BY THE PRACTITIONER AS INDICATED BY THE DULL CONDITION AT TIPS, WHICH MAY HAVE CONTRIBUTED TO THE ABILITY OF THE INSTRUMENT TO PERFORM AS INTENDED. HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES) BY SERIAL NUMBER, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE.

    Description of Event or Problem · 1

    CUSTOMER STATED THE CUTTERS THAT HE WAS USING CAUSED THE WIRE TO DEFLECT INTO A PATIENT'S CHEEK. THERE WAS AN INJURY REQUIRING A PATIENT TO HAVE TO SEE AN ORAL SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713515 HU-FRIEDY 678-101L EIX HU-FRIEDY MFG. CO., LLC 678-101L 0312

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other