BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM AUTOPASS NEEDLE, QTY 5

    MDR report key: 10319509 · Received July 24, 2020

    Report

    Report Number
    1017294-2020-00310
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    June 29, 2020
    Report Date
    January 27, 2026
    Manufacturer
    CLASSIC WIRE CUT CO, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE ROOT CAUSE CANNOT BE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED OF THE VENDOR AND NO ABNORMALITIES WERE INDICATED IN THE VENDOR'S RESPONSE. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF TWO COMPLAINTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNINGS: IF THE SUTURE PASSER NEEDLE KINKS DURING USE, IMMEDIATELY DISCONTINUE USE AND DISCARD. THERE IS AN INCREASED RISK OF NEEDLE BREAKAGE AND UNINTENTIONAL PATIENT INJURY MAY RESULT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SMI-02N WAS BEING USED ON (B)(6) 2020 DURING A CUFF REPAIR WHEN THE TIP OF THE NEEDLE BROKE IN THE INFRA TENDON AND WAS NOT REMOVED. FURTHER ASSESSMENT QUESTIONS WERE REQUESTED, AND IT WAS FOUND THAT THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION DUE TO THIS EVENT; HOWEVER, THE REPORTER DID NOT STATE WHY THE COMPONENT WAS CHOSEN NOT TO BE REMOVED FROM THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE COMPONENT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788169 SPECTRUM AUTOPASS NEEDLE, QTY 5 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CLASSIC WIRE CUT CO, INC. 53918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other