BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, STRAIGHT 12 MM, DIA. 2.2 MM

    MDR report key: 21069011 · Received January 3, 2025

    Report

    Report Number
    1220246-2025-09195
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 9, 2024
    Report Date
    March 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867099982
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-300-B003 BURR, STRAIGHT 12 MM BATCH: 073228 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT IT WAS BROKEN INTO TWO PIECES. DIMENSIONAL TESTING WAS PERFORMED BY MEASURING THE CRITICAL DIMENSION SPECIFIED IN DRAWING C15363 WITH A BLADE MICROMETER. THE MEASUREMENT FOR BOTH FRAGMENTS OF THE RETURNED DEVICE WAS FOUND TO BE 2.345 WHICH IS IN TOLERANCE OF THE SPECIFIED 2.35 -0.016. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MIS CALCANEUS OSTEOTOMY SURGERY THE DEVICE BROKE OFF WHILE DRILLING, WITHOUT LEVERAGE. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A FOREIGN SAWBLADE, THE SURGICAL TECHNIQUE HAD TO CHANGE TO AN OPEN CALCANEUS OSTEOTOMY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670463 BURR, STRAIGHT 12 MM, DIA. 2.2 MM BURR,SURGICAL LXH ARTHREX, INC. BURR, STRAIGHT 12 MM, DIA. 2.2 MM 073228 00888867099982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown