BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT SMALL QUICK COUPLING (SQC) 2.0MM 100/21.5MM

    MDR report key: 20280525 · Received September 23, 2024

    Report

    Report Number
    2249529-2024-00001
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 23, 2024
    Manufacturer
    GSOURCE, LLC
    Product Code
    HTW
    UDI-DI
    00840314246547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 OF FDA 21 CFR. BASED ON THE INVESTIGATION INTO THE COMPLAINT CC#(B)(6) REGARDING THE BROKEN DRILL BIT WHICH REMAINED IN PATIENT'S BODY AFTER TOTAL HIP ARTHROPLASTY SURGERY (PART# GS 86.8220 AND LOT# 5232413), IT WAS FOUND THAT NO DEVICE WAS RETURNED FOR EVALUATION, AND LIMITED DETAILS WERE PROVIDED ABOUT THE INCIDENT (I.E. UNKNOWN ABOUT HOW AND WHEN THE DRILL BROKE, POSITION OF BREAKAGE, ETC.). THE MANUFACTURING AND FINAL QA RELEASE PAPERWORK REVIEW CONFIRMED THAT THE PRODUCT CONFORMED TO SPECIFICATIONS. TESTING OF FINISHED PIECES FROM DIFFERENT BATCHES OF THE SAME PART NUMBER WAS PERFORMED IN-HOUSE WHICH DID NOT YIELD ANY FAILURES OF BREAKING, INDICATING THAT THERE IS NO EVIDENCE OF A DESIGN OR MANUFACTURING ISSUE. AS THE ROOT CAUSE CANNOT BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE PROPOSED AT THIS TIME. HOWEVER, A SUGGESTION FOR MEDICAL PROFESSIONALS IS TO CONSIDER USING A TWIST DRILL (GS 86.8420) INSTEAD OF THE SQC DRILL BIT (GS 86.8220) DURING COMPLEX PROCEDURES LIKE HIP ARTHROPLASTY. THE TWIST DRILL'S CONSISTENT DIAMETER THROUGHOUT ITS LENGTH REDUCES THE RISK OF BUCKLING, WHICH CAN OCCUR WITH SMALLER DIAMETER DRILL BITS THAT HAVE A CHANGE IN DIAMETER. THIS RECOMMENDATION AIMS TO ENHANCE INSTRUMENT RELIABILITY WHILE PERFORMING DENSE AND COMPLEX SURGERIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SQC DRILL BIT BROKE DURING TOTAL HIP ARTHROPLASTY SURGERY AND THE BROKEN DRILL IT REMAINED IN PATIENTS BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502468 DRILL BIT SMALL QUICK COUPLING (SQC) 2.0MM 100/21.5MM DRILL BIT SQC HTW GSOURCE, LLC GS 86.8220 5232413 00840314246547

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other