BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 6977668 · Received October 25, 2017

    Report

    Report Number
    3010692967-2017-00001
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    February 3, 2017
    Report Date
    April 7, 2017
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL BROKEN DEVICE WAS DISCARDED BY THE END USER. STERILE PRODUCT FROM THE REPORTED LOT WERE RETURNED FOR REVIEW/TESTING ON 4/1/2017. -RESULTS/CONCLUSIONS: THE STERILE DEVICES WERE BEND/DUCTILITY TESTED PER CURRENT CRITERIA AND MET ALL REQUIREMENTS FOR THIS SIZE/TYPE NEEDLE DEVICE. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENT LOTS MET CURRENT USP AND SURGICAL SPECIALTIES MEXICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. WITHOUT RECEIVING DETAILED INFORMATION REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICE, ACTUAL PROCEDURE, OR THE SURGEON'S TECHNIQUE A DEFINITIVE ROOT CAUSE FOR THE NEEDLE BREAKING DURING THE PROCEDURE CANNOT BE DETERMINED WITH CERTAINTY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE BROKE WHILE CLOSING A WOUND ON THE BACK. AN X-RAY WAS REQUIRED TO LOCATE THE NEEDLE SEGMENT RETAINED IN THE WOUND. THE SEGMENT WAS REMOVED WITH RADIOLOGIC GUIDANCE WITHOUT FURTHER INCIDENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754969 HENRY SCHEIN 4-0 BLACK MONO NYLON C-3 REV CUTTING NEEDLE GAB SURGICAL SPECIALTIES CORPORATION 900-7466 AAAG767

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Required Intervention