BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFCC MENDER DISPOSABLE SUTURE SYSTEM

    MDR report key: 9772685 · Received March 1, 2020

    Report

    Report Number
    1219602-2020-00448
    Event Type
    Malfunction
    Date Received
    March 1, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 31, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWQ
    UDI-DI
    03596010563279
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. ON (B)(6) 2020, SMITH & NEPHEW RECEIVED A COMPLAINT AGAINST TWO TFCC MENDER DISPOSABLE SUTURE SYSTEM DEVICES (PART NUMBER: 7210752; LOT NUMBERS: 50646756 (X1) & 50727527 (X1)). IT WAS REPORTED THAT, DURING A KNEE SURGERY, TWO SCREWS BROKE WHILE BEING TAPPED. IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK UP SCREW WENT IN AND HELD. IT IS UNKNOWN HOW LONG SURGERY WAS DELAYED. THE PATIENT WAS NOT HARMED. CONSEQUENTLY, ON (B)(6) , SMITH & NEPHEW FILED TWO REPORTS FOR THIS INCIDENT: 1219602-2020-00448 & 1219602-2020-00449 (ONE FOR EACH DEVICE). THE REPORTING DECISION WAS THEN MADE BASED ON TWO CRITERIA: (1) AN INTRAOPERATIVE BREAKAGE; AND (2) THE LACK OF A BACK-UP DEVICE. NONETHELESS, ON (B)(6) 2020, THE REPORTING SOURCE INDICATED THAT THE INITIAL INFORMATION WAS ERRONEOUS AND PROCEEDED TO AMEND AS FOLLOWS: IT WAS REPORTED THAT, DURING A KNEE SURGERY, TWO TFCC MENDER SUTURE SYSTEMS BROKE AS THEY CAME OUT OF THE PACKAGING. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED, BUT IS UNKNOWN FOR HOW LONG. THE PATIENT WAS NOT HARMED. THEREFORE, THE RE-ASSESSMENT OF THIS CASE DETERMINED THAT, SINCE THE PREVIOUSLY ENLISTED CRITERIA 1-2 ARE NO LONGER MET, THE ISSUE DOES NOT MEET EITHER THE THRESHOLD FOR REPORTING AND IS NOW A NON-REPORTABLE EVENT. THESE REPORTS WERE SUBMITTED BASED UPON INFORMATION THAT SMITH & NEPHEW HAD NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A KNEE SURGERY, A SCREW BROKE WHILE BEING TAPPED. IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP SCREW WENT IN AND HELD. IT IS UNKNOWN HOW LONG SURGERY WAS DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236317 TFCC MENDER DISPOSABLE SUTURE SYSTEM PASSER HWQ SMITH & NEPHEW, INC. 7210752 50646756 03596010563279

    Patients

    Seq Age Sex Outcome Treatment
    1