BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, OVAL, 12 FLUTE 5.5MM X 13CM

    MDR report key: 8114738 · Received November 29, 2018

    Report

    Report Number
    1220246-2018-00770
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    October 29, 2018
    Report Date
    June 8, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867044050
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. VISUAL EVALUATION REVEALED HEAT DAMAGE ACROSS THE OD OF THE AR-8550OBT OUTER TUBE. THE 304L STAINLESS STEEL WAS OBSERVED TO HAVE PATCHES OF DISCOLORATION INDICATIVE OF HIGH HEAT EXPOSURE ALONG THE OD OF THE DEVICE. THE CAUSE IS ATTRIBUTED TO A SUPPLIER PROCESS AND TWO ROOT CAUSES WERE IDENTIFIED: MATERIAL AND MEASUREMENT. MATERIAL: MATERIAL IS CONSIDERED TO BE A ROOT CAUSE AS COMPONENTS THAT DID NOT MEET SPECIFICATION CONTRIBUTED TO THE EVENT. BECAUSE THE HEAT SHRINK RECOVERED OUTER DIAMETER AND THE OUTER TUBE INNER DIAMETER WERE OVERSIZED AND UNDERSIZED RESPECTIVELY, PROPER CLEARANCE DID NOT EXIST BETWEEN THE BURR COMPONENTS WHICH CAUSE THE GENERATION OF HEAT. MEASUREMENT: MEASUREMENT IS CONSIDERED TO BE A ROOT CAUSE DUE TO THE INADEQUATE "SPINS FREELY" TEST WHICH ALLOWED NONCONFORMING MATERIAL TO BE ACCEPTED INTO INVENTORY.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. VISUAL EVALUATION REVEALED HEAT DAMAGE ACROSS THE OD (OUTER DIAMETER) OF THE AR-8550OBT OUTER TUBE. THE 304L STAINLESS STEEL WAS OBSERVED TO HAVE PATCHES OF DISCOLORATION INDICATIVE OF HIGH HEAT EXPOSURE ALONG THE OD OF THE DEVICE. THIS EVENT IS MOST LIKELY OBSERVED WHEN THE END USER DOES NOT HAVE FLUID OR HAS LOW FLUID FLOWING THROUGH THE DEVICE DURING USE.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. VISUAL EVALUATION REVEALED HEAT DAMAGE ACROSS THE OUTER DIAMETER OF THE AR-8550OBT OUTER TUBE. THE 304L STAINLESS STEEL WAS OBSERVED TO HAVE PATCHES OF DISCOLORATION INDICATIVE OF HIGH HEAT EXPOSURE ALONG THE OUTER DIAMETER OF THE DEVICE. THIS EVENT IS MOST LIKELY OBSERVED WHEN THE END USER DOES NOT HAVE FLUID OR HAS LOW FLUID FLOWING THROUGH THE DEVICE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THEY WERE USING THE BURR TO RESECTION 5MM OF DISTAL CLAVICLE. THEY WERE HEARING A HIGH PITCHED NOISE, WHICH THEY THOUGHT WAS FROM THE SHAVER SO THEY REPLACED THE SHAVER. THEY RECONNECTED THE BURR TO ANOTHER SHAVER. THE NOISE CONTINUED AND THE SHAFT OF THE BURR GOT TOO HOT TO TOUCH AND THE PATIENT GOT BURNED AT THE POSTERIOR PORTAL. THEY USED SILVER COMPOUND ON THE WOUND. THERE WERE NO ADDITIONAL INCISIONS OR HOSPITALIZATION REQUIRED AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955085 BURR, OVAL, 12 FLUTE 5.5MM X 13CM BURR, SURGICAL, GENERAL & PLASTIC SURGERY GFF ARTHREX, INC. BURR, OVAL, 12 FLUTE 5.5MM X 13CM 10211276 00888867044050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other