BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT CALIBRATED 200MM

    MDR report key: 18279295 · Received December 6, 2023

    Report

    Report Number
    3011656326-2023-00002
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    April 7, 2022
    Report Date
    December 6, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HTW
    UDI-DI
    00816950028373
    PMA / PMN Number
    K152000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF OSTEOCENTRIC TECHNOLOGIES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    UDI RELEATED 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, FULL UDI, AND 510(K) NUMBER, WHICH WERE MISSING FROM THE INITIAL REPORT. THE LOT # AND MANUFACTURING DATE ARE ON THE DEVICE LABEL, BUT ARE NOT ON THE LABEL AS A PI. THIS REPORT SPECIFIES THAT THIS IS NOT A COMBINATION PRODUCT. THIS REPORT CORRECTS THE MANUFACTURE DATE. 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

    IT WAS REPORTED THAT A 2.5MM CALIBRATED DRILL BIT PART #110040 LOT# DAL008 WAS USED TO DRILL 3 PILOT HOLES IN THE PELVIS. ON THE THIRD HOLE THE DRILL BIT TIP BROKE OFF IN THE PATIENT. THE SURGEON INDICATED HE USED A NEW DRILL AND PROPER SCREW FIXATION PROCEEDED. THE SURGEON INDICATED THAT HE WAS USING THE DRILL OUTSIDE OF NORMAL USE. THE REMAINING PORTION OF THE DRILL BIT WAS DISCARDED AND THEREFORE COULD NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211718 2.5MM DRILL BIT CALIBRATED 200MM 2.5MM X 200MM CALIBRATED DRILL BIT HTW OSTEOCENTRIC TECHNOLOGIES, INC. 110040 DAL008 00816950028373

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other