BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20287002 · Received September 23, 2024

    Report

    Report Number
    2249529-2024-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 23, 2024
    Manufacturer
    GSOURCE, LLC
    Product Code
    HTW
    UDI-DI
    00840314246547
    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 DETAILS THE INVESTIGATION ( (B)(4) ) INTO THE BREAKAGE OF THREE DRILL BITS USED IN ORTHOPEDIC SURGERIES, AS REPORTED IN THREE SEPARATE MEDICAL DEVICE REPORTS (MDRS). PART NUMBER: GS 86.8220, LOT NUMBER: 5232413, USER FACILITY MDR REFERENCES: MW5158653, MW5158654, MW5158655, REFERENCE TO ANOTHER COMPLAINT: (B)(4), [MDR# 2249529-2024-00001]. ALL THREE MDRS REFERENCE THE SAME PATIENT DETAILS, INDICATING A HIGH LIKELIHOOD OF DUPLICATE REPORTING BY THE USER FACILITY. EMAIL COMMUNICATIONS CONFIRM THAT ONLY ONE REPORT WAS INTENDED FOR SUBMISSION THE SPECIFIC ORTHOPEDIC SURGERIES PERFORMED WERE NOT DETAILED IN THE REPORTS, LIMITING OUR UNDERSTANDING OF THE CONTEXT. DESPITE MULTIPLE REQUESTS, NO BROKEN DRILL BITS WERE RETURNED FOR EVALUATION. FINDINGS INDICATE NO DESIGN OR MANUFACTURING DEFECTS. PRODUCTION AND FINAL QUALITY ASSURANCE (QA) REVIEWS (DHR) CONFIRM COMPLIANCE WITH SPECIFICATIONS. IN-HOUSE TESTING WAS CONDUCTED ON DRILL BITS FROM A DIFFERENT LOT REVEALED NO BREAKAGE DURING TESTING. 50 DRILL BITS FROM LOT # 5232413 WERE PRODUCED AND NO ADDITIONAL COMPLAINTS FROM OTHER CUSTOMERS USING THIS LOT, INDICATING THAT THE REPORTED ISSUES MAY BE ISOLATED. IT IS LIKELY THAT THE SAME SURGEON PERFORMED THE REPORTED SURGERIES. THIS RAISES THE POSSIBILITY THAT SURGICAL TECHNIQUE MAY HAVE INFLUENCED THE INCIDENTS. THE INVESTIGATION REVEALS NO INHERENT ISSUES WITH THE DRILL BITS. THE BREAKAGES APPEAR TO BE ISOLATED CASES AS SURGICAL TECHNIQUE CANNOT BE RULED OUT AS A CAUSE. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DRILL BIT BROKE DURING ORTHOPEDIC SURGERY AND THE BROKEN DRILL BIT WAS RETRIEVED FROM THE PATIENT'S BODY. THIS IS A RECURRING EVENT PER HOSPITAL INVOLING SAME DRILL BIT WITH SAME LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016691 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 70 YR Male