BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0/2.4/3.0/4.0MM SCREW EXTRACTOR

    MDR report key: 19742718 · Received July 15, 2024

    Report

    Report Number
    2027754-2024-00037
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS PENDING EVALUATION OF THE DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AND EXPLANT SURGERY TO REMOVE A FUSION PLATE AND SCREW DUE TO A FAILED FUSION. DURING THE EXPLANT SURGERY, THE PART NUMBER 316-0009 SCREW EXTRACTOR BROKE. THE FUSION SCREW AND EXTRACTOR TIP WERE REMOVED, AND THE SURGERY WAS COMPLETED. THIS ISSUE PROLONGED THE SURGERY BY 2-3 MINUTES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED DEVICES COULD NOT BE PERFORMED AS BATCH/LOT NUMBERS ARE UNKNOWN. THE REPORTED SCREW AND PLATE HAD BEEN DISCARDED BY THE FACILITY AND WERE NOT AVAILABLE FOR EVALUATION. THE REPORTED PART NUMBER 316-0009 SCREW EXTRACTOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE TIP OF THE SCREW EXTRACTOR HAD FRACTURED. A REVIEW OF THE COMPLAINT DATABASE FOR PART NUMBER 316-0009 REVEALED THREE (3) COMPLAINTS, ALL OF WHICH WERE REPORTS OF BREAKAGE DURING USE. POTENTIAL CAUSES FOR THE REPORTED SCREW EXTRACTOR BREAKAGE EVENT COULD INCLUDE USER ERROR AND INADEQUATE DESIGN. ADDITIONALLY, IT IS UNKNOWN AFTER HOW LONG THE DEVICES HAD BEEN IMPLANTED PRIOR TO THE EXPLANT SURGERY, BONY ONGROWTH COULD HAVE BEEN A CONTRIBUTING FACTOR. HOWEVER, BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: INVESTIGATION FINDINGS CODE UPDATED TO: 3243. INVESTIGATION CONCLUSION CODE UPDATED TO: 4315.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A FAILED FUSION (EVENT DATE UNKNOWN), AND AN EXPLANT/REMOVAL SURGERY WAS BEING PERFORMED. DURING THE REMOVAL SURGERY ON (B)(6) 2024, THE SURGEON WAS REMOVING A 1.6MM HAND FUSION PLATE. THE DRIVER TIP WAS NOT FULLY SEATING IN THE HEAD OF THE FUSION SCREW, EVEN WHEN "UTILIZING" A K-WIRE. THE SURGEON ATTEMPTED TO USE THE 2.0/2.0/3.0/4.0 SCREW EXTRACTOR (PART NUMBER 316-0009) TO REMOVE THE FUSION SCREW, AND THE TIP OF THE EXTRACTOR BROKE OFF INSIDE THE FUSION SCREW. THE FUSION SCREW AND EXTRACTOR TIP WERE REMOVED FROM THE PATIENT, AND THE EXPLANT SURGERY WAS COMPLETED. THIS ISSUE PROLONGED THE EXPLANT SURGERY BY 2-3 MINUTES. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285114 2.0/2.4/3.0/4.0MM SCREW EXTRACTOR SCREW, FIXATION, BONE HWC OSTEOMED, LLC 316-0009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female