BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI SYSTEM

    MDR report key: 11839266 · Received May 17, 2021

    Report

    Report Number
    3008650117-2021-00090
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 17, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR P99-190-TX06 LOT TC21338 WAS CONDUCTED AND ALL RECEIVED PARTS WERE ACCEPTED. NO NCR IDENTIFIED. VISUAL OBSERVATION OF THE RETURNED IMAGE CONFIRMED THE FAILURE MODE THAT THE TIP OF THE DRIVER IS BROKEN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    PROBLEM WITH PARAGON 28 CANNULATED SCREW DRIVER (P99-190-TX06) WAS REPORTED, WHERE THE DRIVER BROKE DURING USE. IT WAS IDENTIFIED THAT THIS FAILURE MODE CAUSED A DELAY IN SURGERY FOR OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735394 MULTI SYSTEM SCREW DRIVER ATTACHMENT, CANNULATED, AO, HX-6 HWC PARAGON 28, INC. P99-190-TX06 TC21338

    Patients

    Seq Age Sex Outcome Treatment
    1 P99-000-AOMN MINI-AO, RATCHETING HANDLE