BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL

    MDR report key: 8580688 · Received May 4, 2019

    Report

    Report Number
    8010099-2019-00007
    Event Type
    Malfunction
    Date Received
    May 4, 2019
    Date of Event
    September 25, 2018
    Report Date
    May 4, 2019
    Manufacturer
    MEDICON E.G.
    Product Code
    HTW
    UDI-DI
    04046826312350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS CHECKED AND CONFORMED TO SPECIFICATIONS, INCLUDING DEVICE HARDNESS. THE RETURNED DEVICE WAS INSPECTED AND FOUND TO HAVE FRACTURED AT THE WEAKEST SPOT, THE THREAD RUN-OUT. DIMENSIONS WERE VERIFIED AND CONFORM TO SPECIFICATIONS. THE MICROSTRUCTURE OF THE DRILL IS HOMOGENOUS AND SHOWS NO ANOMALIES. THE DRILL CORE WAS MEASURED AT THE FRACTURE POINT AND FOUND TO CONFORM TO SPECIFICATIONS. THE FRACTURE SURFACE REVEALS THAT THE DRILL WAS STRONGLY BENT, AS CAN OCCUR WHEN A DRILL IS POSITIONED OBLIQUELY OR SUBJECT TO EXCESSIVE TORSION FORCE DURING USE. BONE RESIDUE WAS FOUND IN THE THREAD RUN-OUT AREA, INDICATING THAT THE DRILL DID NOT FRACTURE IMMEDIATELY AS STATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE HANDPIECE AND THE ROTATIONAL SPEED USED DURING THE OPERATION. [(B)(4)].

    Description of Event or Problem · 1

    IN ACCORDANCE WITH THE SURGEON'S REPORT, DURING PLASTIC SURGERY HE ATTEMPTED TO USE A TWIST DRILL, BUT THE DEVICE BROKE IMMEDIATELY. IT WAS REPLACED BY AN IDENTICAL DRILL BIT FROM THE SAME LOT, WHICH ALSO BROKE IMMEDIATELY. THE FRACTURED TIP OF THE SECOND DRILL WAS DEFLECTED BY THE BONE AND FLEW AT THE SURGEON'S FACE, BARELY MISSING HIS EYE. NO PATIENT HARM. THIS REPORT IS FOR DEVICE #1 OF 2 USED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374062 TWIST DRILL DRILL HTW MEDICON E.G. PF17245 04046826312350

    Patients

    Seq Age Sex Outcome Treatment
    1