BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FAST-FIX 360

    MDR report key: 16303981 · Received February 6, 2023

    Report

    Report Number
    1219602-2023-00142
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    December 15, 2022
    Report Date
    March 7, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ONE OF THE FOLLOWING DEVICES CAUSED THE NEED FOR A MENISCECTOMY: PN 72202468; LOT#: 2095238 OR 2100094, PN 72203720; LOT#: 2091839.

    Additional Manufacturer Narrative · 0

    H10: THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. ADDITIONAL INFORMATION RECEIVED BY REPORTER STATES THAT IT IS UNKNOWN WHETHER THE MENISCECTOMY WAS PERFORMED.  IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY, AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WHITE PROTECTION SLEEVE OF THREE FAST FIX 360 WAS SHORTER THAN USUAL, THEREFORE IT COULD NOT PROTECT THE IMPLANTS CORRECTLY. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING THE TECHNIQUE TO A MENISCECTOMY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WHITE PROTECTION SLEEVE OF THREE FAST FIX 360 WAS SHORTER THAN USUAL, THEREFORE IT COULD NOT PROTECT THE IMPLANTS CORRECTLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A NON-SIGNIFICANT DELAY WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81632 UNKNOWN FAST-FIX 360 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 UNKNOWN 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other