BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM T20 SCREWDRIVER SHAFT

    MDR report key: 2900050 · Received January 7, 2013

    Report

    Report Number
    1526439-2013-10547
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    September 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTS THE SAMPLE WILL NOT BE RETURNED FOR EVALUATION. THE LOT CODE IS UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. (B)(4): DEVICE RETAINED BY CUSTOMER.

    Description of Event or Problem · 1

    MEDWATCH 3500A USER FACILITY (B)(4) RECEIVED FROM FDA REPORTING DEVICE BREAKAGE. SCREWDRIVER BROKE OFF DURING SURGERY. BOTH PIECES RECOVERED. X-RAY TAKEN AT END OF SURGERY TO VERIFY NO FOREIGN BODIES AND WAS NEGATIVE. NO DELAY TO THE SURGICAL PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7916 EXPEDIUM T20 SCREWDRIVER SHAFT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1