BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ES2 CANNULATED MODULAR TAP

    MDR report key: 6071411 · Received November 1, 2016

    Report

    Report Number
    0009617544-2016-00439
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 9, 2016
    Report Date
    January 12, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    UDI-DI
    04546540710413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 150918. METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE DEVICE WAS INSPECTED AND IT WAS CONFIRMED THAT THE TAP TIP WAS FRACTURED. MANUFACTURING FILES WERE REVIEWED AND NO ANOMALIES WERE FOUND. AWL WAS NOT USED. CONCLUSION: THE PROBABLE ROOT CAUSES OF THIS EVENT ARE USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A MEDICAL PROCEDURE THE NEUROSURGEON USED THE TAP TROUGH A WIRE. WHEN INTRODUCING THE TAP IN S1, THE SURGEON, WHEN CONTROLLING, NOTED THAT THERE WERE FRAGMENTS. THE MOUTHPIECE OF THE TAP BROKE INTO PIECES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A MEDICAL PROCEDURE THE NEUROSURGEON USED THE TAP TROUGH A WIRE. WHEN INTRODUCING THE TAP IN S1, THE SURGEON, WHEN CONTROLLING, NOTED THAT THERE WERE FRAGMENTS. THE MOUTHPIECE OF THE TAP BROKE INTO PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721861 ES2 CANNULATED MODULAR TAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE UNKNOWN 04546540710413

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention