BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFIX

    MDR report key: 4759528 · Received May 6, 2015

    Report

    Report Number
    9680024-2015-00001
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 29, 2015
    Manufacturer
    SMALL BONE INNOVATIONS INTERNATIONAL, S.A.S.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: VISUAL INSPECTION: BREAKAGE OF DEVICE WAS CONFIRMED. DIMENSIONAL INSPECTION: THE DEVICE RECORD SHOWS NO NON-COMPLIANCE IN MANUFACTURING. CONCLUSIONS: THE VISUAL INSPECTION CONFIRMS THAT THE TIP OF THE DEVICE IS BROKEN. WE CAN CONCLUDE THE INCIDENT IS NOT DUE TO A MANUFACTURE ISSUE BUT IS A USER RELATED ISSUE.

    Description of Event or Problem · 1

    AN INSTRUMENT NURSE MISTAKENLY HANDED THE SURGEON A COUNTERSINK INSTEAD OF A SCREWDRIVER. THE SURGEON USED THE COUNTERSINK WITHOUT BEING AWARE OF THE MISTAKE. AS THE RESULTS, THE TIP OF THE COUNTERSINK BROKE AND REMAINED INSIDE THE PATIENT'S BODY. THE FLUOROSCOPY SHOWED A FOREIGN BODY, THE SURGEON CARRIED OUT THE IRRIGATION OF THE SURGICAL SITE AND THE SUCTION OF THE IRRIGATION FLUID. AFTER CONFIRMING WITH FLUOROSCOPY THAT THE FOREIGN BODY WAS REMOVED FROM THE SURGICAL SITE, THE SURGEON CLOSED THE WOUND. IN THE POSTOPERATIVE X-RAYS, NO FOREIGN BODY WAS DETECTED. THE SURGEON AND THE MEDICAL STAFF POSTOPERATIVELY CHECKED THE COUNTERSINK AND FOUND THAT ITS TIP WAS BROKEN. THEREFORE, THEY SUPPOSED THAT THE FOREIGN BODY SHOWN IN THE FLUOROSCOPY DURING THE OPERATION WAS THE TIP OF THE COUNTERSINK. THEY ALSO CHECKED THE SUCKED IRRIGATION FLUID AND OTHERS, BUT COULD FIND NO FOREIGN BODY. ALTHOUGH THE SURGEON INDICATED THAT THIS INCIDENT WAS ATTRIBUTABLE TO A MISTAKE MADE BY THE MEDICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296800 AUTOFIX HWW ORTHOPEDIC MANUAL SURGICAL INSTR HWC SMALL BONE INNOVATIONS INTERNATIONAL, S.A.S. X0865

    Patients

    Seq Age Sex Outcome Treatment
    1 Other