BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS NEEDLES

    MDR report key: 3751641 · Received April 15, 2014

    Report

    Report Number
    1219602-2014-00114
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE TRUEPASS SELF-CAPTURE SUTURE PASSER AND ONE TRUEPASS NEEDLE WERE RETURNED FOR EVALUATION. A REVIEW OF THE RETURNED NEEDLE CONFIRMS THE DISTAL TIP OF THE NEEDLE HAS BROKEN OFF. THE REMAINING PORTION OF THE NEEDLE HAS A SIGNIFICANT AMOUNT OF BEND. THE RETURNED PORTION OF NEEDLE WAS MEASURED IN THICKNESS AND WIDTH AND CONFIRMED TO BE WITHIN SPECIFICATION. THE WELD IS INTACT AND THE REMAINING PORTION OF THE NEEDLE TIP SHOWS EVIDENCE OF DURAGLIDE OVER THE REQUIRED LENGTH. IT APPEARS THAT THE TIP OF THE NEEDLE WAS OVER BENT AT THE TIP WHICH CAUSED THE NEEDLE BREAKAGE. IN AN EFFORT TO DETERMINE IF THE TRUEPASS SELF-CAPTURE SUTURE PASSER CONTRIBUTED TO THE BREAKAGE THE RETURNED DEVICE WAS ACTUATED WITH A NEW NEEDLE IN EXCESS OF 50 TIMES THROUGH SIMULATED CUFF AND THEN AGAIN WITH A SECOND NEEDLE. THE DEVICE FUNCTIONED AS EXPECTED WITH NO OBSERVED ANOMALIES AND NO NEEDLE BREAKAGE. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE PRODUCT CAN BE DETERMINED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A ROTATOR CUFF REPAIR PROCEDURE UTILIZING A TRUEPASS NEEDLE, SINGLE PACK, STERILE BX 5 WITH A TRUEPASS SUTURE PASSER, SELF-CAPTURE, IT WAS REPORTED THAT THE NEEDLE BROKE. THE BROKEN NEEDLE WAS DISCOVERED AFTER THE COMPLETED PROCEDURE. AN X-RAY TAKEN BY THE SURGEON AT THE FOLLOW UP APPOINTMENT CONFIRMED THAT THE NEEDLE TIP WAS INSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230194 ELITE PASS NEEDLES TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5 NBH MANSFIELD MANUFACTURING SITE 72203793 50491220

    Patients

    Seq Age Sex Outcome Treatment
    1