BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE 1.1MM, SMOOTH, SINGLE TROCAR

    MDR report key: 18288438 · Received December 7, 2023

    Report

    Report Number
    3011656326-2023-00006
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    July 8, 2021
    Report Date
    December 7, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HTY
    UDI-DI
    00850015496264
    PMA / PMN Number
    K200259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GUIDE WIRE CAN ALSO BE DEFORMED DURING A TRANSITION THROUGH A JOINT IN WHICH MOVEMENT OF THE JOINT DURING FIXATION, OR PIN DEFLECTION CROSSING THE JOINT SPACE, CREATES A SLIGHT CHANGE IN DIRECTION. THIS CHANGE OF DIRECTION CAN HAMPER SMOOTH PASSAGE OF THE DRILL BIT OVER THE GUIDE PIN AND CAN ERODE THE PIN, CREATING A STRESS RISER IN THE PIN THAT RESULTS IN BREAKAGE.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES, PRODUCT INFORMATION UPDATE, INITIAL REPORTER UPDATES, & REPORT SOURCE UPDATE: THIS FOLLOW-UP REPORT INCLUDES THE ADDITION OF THE BRAND NAME, MODEL NUMBER, AND FULL UDI, WHICH WERE MISSING FROM THE INITIAL REPORT. THIS REPORT WAS UPDATED TO INCLUDE CORRECTED 510(K). THIS REPORT INDICATES THAT THE REPORT PRODUCT IS FOR SINGLE USE. THIS REPORT SPECIFIES THAT THIS IS NOT A COMBINATION PRODUCT. ADDITIONALLY, THIS REPORT UPDATES THE INITIAL REPORTER INFORMATION TO THE PHYSICIAN WHO INITIALLY REPORTED THE ISSUE AND INCLUDES THE REPORT SOURCE OF HOW THE ISSUE BECAME KNOWN BY OSTEOCENTRIC TECHNOLOGIES, INC.

    Description of Event or Problem · 0

    TWO 1.1MM KWIRES BROKE OFF DURING A HAND SURGERY. THE DOCTOR MENTIONED THAT THEY BROKE WITHIN THE BONE. THE BONE IN THIS AREA IS VERY HARD BONE. ONE BROKEN WIRE APPEARS TO BE ANGLED TO A POINT THAT WHEN THE FASTENER WAS INSERTED IN PUSHED AGAINST THEY WIRE CAUSING THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220655 K-WIRE 1.1MM, SMOOTH, SINGLE TROCAR 1.1MM HCS K-WIRE SMOOTH HTY OSTEOCENTRIC TECHNOLOGIES, INC. EX01-0028 00850015496264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other