BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø2.0MM (6¿) DRILL

    MDR report key: 14567926 · Received June 1, 2022

    Report

    Report Number
    3012966183-2022-00019
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 1, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR LOT# 19155AT08. THERE WERE NO CAPAS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET ALL SPECIFICATIONS. THE LOT CONSISTED OF 133 PIECES.THE LOT MET ALL SPECIFICATIONS AND WAS RELEASED.A HISTORICAL DATA REVIEW FOR PART NUMBER T001120116 SPANNING 18 MONTHS REVEALED 5 COMPLAINTS IN WHICH 4 WERE FOR FRACTURED INSTRUMENTS. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED FOR THE COMPLAINT TYPE. A REVIEW OF TEST REPORT TR#201907 BIOCOMPATIBILITY EVALUATION DEMONSTRATE THAT THE DRILL MATERIAL WAS BIOCOMPATIBLE. BIOCOMPATIBILITY TESTING MET THE PASSING CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 1ST DRILL BIT BROKE AND WAS LEFT IN PATIENT(TIP OF DRILL). 2ND DRILL BIT STARTED TO BREAK AND DOCTOR STOPPED USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730641 Ø2.0MM (6¿) DRILL DRILL LXH TYBER MEDICAL T001120116 19155AT08

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other