BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE NEEDLE SHUTTLE STERILE

    MDR report key: 4964777 · Received August 4, 2015

    Report

    Report Number
    1219602-2015-00686
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ONE SUTURE SHUTTLE NEEDLE WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE NEEDLE CONFIRMED THE REPORTED COMPLAINT OF BREAKAGE. THE DISTAL TIP HAS BROKEN OFF AT THE SUTURE PICK-UP SLOT. THE REMAINING PORTION OF THE NEEDLE WAS INSPECTED DIMENSIONALLY AND FOUND TO MEET PRINT REQUIREMENTS. DUE TO THESE OBSERVATIONS NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CAN BE ESTABLISHED. (B)(4).

    Description of Event or Problem · 1

    DURING A ROTATOR CUFF REPAIR, WHEN USING ULTRABRAID TO REPAIR PRIMARY ROTATOR CUFF TEAR, THE NEEDLE STRUGGLED TO GO THROUGH DEVICE AND TIP OF NEEDLE BROKE OFF. IT WAS REPORTED THAT THE SHOULDER WAS RINSED AND UPON INSPECTION, BROKEN PIECE COULD NOT BE OBSERVED ANYMORE. THERE WAS A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A ONE MINUTE PROCEDURAL DELAY. IT WAS REPORTED THAT JUST THE TIP OF THE NEEDLE HAD BROKEN OFF. THERE ARE NO COMPUTERIZED TOMOGRAPHY CT/ MAGNETIC RESONANCE IMAGING MRI/X-RAY IMAGES AVAILABLE FOR THE FILE. THERE WAS NO REPORTED PATIENT INJURY OR SURGICAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508420 SUTURE NEEDLE SHUTTLE STERILE PASSER HWQ SMITH & NEPHEW, INC. 50478035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention