BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE RASP HANDLE

    MDR report key: 6080558 · Received November 4, 2016

    Report

    Report Number
    0009617544-2016-00442
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 10, 2016
    Report Date
    January 13, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    UDI-DI
    07613327269116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 134002. METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED FOR THE REPORTED LOT. THE DEVICE WAS INSPECTED AND IT WAS FOUND THAT THE TIP OF THE SLIDE RASP HANDLE WAS FRACTURED. CONCLUSION: THE AGE OF THE DEVICE (MORE THAN 3 YEARS) CONCLUDES PLAUSIBLE ROOT CAUSE TO BE "NORMAL WEAR BASED ON AGE AND EXTENSIVE USE OF THE DEVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; TRIAL HANDLE BROKE OFF IN ALIF TRIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; TRIAL HANDLE BROKE OFF IN ALIF TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731151 SLIDE RASP HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE UNKNOWN 07613327269116

    Patients

    Seq Age Sex Outcome Treatment
    1