BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ARTHREX SUREFIRE SCORPION NEEDLE

    MDR report key: 6088126 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00007
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    April 15, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HWQ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE LOT NUMBER OF THE FAILED DEVICE COULD NOT BE DETERMINED. THEREFORE, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE INSTRUCTIONS FOR USE WARN THE USER THAT THE TIP OF THE DEVICE MAY BREAK IF EXCESSIVE FORCE IS APPLIED, AND THAT THE USE OF FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIED TISSUE, OR STRIKING BONE, CAN CAUSE NEEDLE BREAKAGE AND PATIENT INJURY. IT IS RECOMMENDED TO REPOSITION THE NEEDLE TO PASS THROUGH A DIFFERENT AREA. ALTHOUGH THE DEVICE WAS NOT RETURNED FOR EVALUATION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT IN AN ABUNDANCE OF CAUTION. (B)(4).

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT THAT THE TIP OF A REPROCESSED ARTHREX SUREFIRE SCORPION NEEDLE DETACHED DURING THE COURSE OF SURGERY. IT IS NOT KNOWN IF THE TIP OF THE NEEDLE WAS RETRIEVED, HOWEVER THE REPORT STATED THAT THE PATIENT WAS NOT HARMED. THE DEVICE WAS NOT RETURNED TO MEDLINE RENEWAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738238 MEDLINE RENEWAL REPROCESSED ARTHREX SUREFIRE SCORPION NEEDLE SUTURE PASSER HWQ MEDLINE RENEWAL AR-13991N UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention