BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDTRAP WHITE 30MM 4PK

    MDR report key: 8185784 · Received December 20, 2018

    Report

    Report Number
    1221934-2018-55794
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    January 26, 2018
    Report Date
    January 26, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    GAT
    UDI-DI
    10886705027163
    PMA / PMN Number
    K161638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (223749), LOT (L193694) COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED, AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4). ASSOCIATED MEDWATCH: 1221934-2018-55793.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL REPAIR THE SURGEON TRIED TO USE SPEED TRAP BUT 4 OF THE DEVICES MALFUNCTIONED. THERE ARE NO PATIENT CONSEQUENCES. THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 12/14/18 FROM SALES REPRESENTATIVE STATING: THE FACILITY NAME AND ADDRESS. THE PRODUCT BEING REPORTED WAS BEING USED DURING AN ACL RECONSTRUCTION. THE FAILURE WITH THE (2) PRODUCT CODE: 223749 - SUTURE PULLED OFF THE PLASTIC PART OF DEVICE BEFORE IT COULD BE FULLY PULLED ONTO THE GRAFT. THE PROCEDURE WAS COMPLETED BY USING THE ARTHREX FIBERLOOP. THERE WERE NO DELAYS OR PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024773 SPEEDTRAP WHITE 30MM 4PK POLYETHYLENE SUTURE GAT MEDOS INTERNATIONAL SARL L193694 10886705027163

    Patients

    Seq Age Sex Outcome Treatment
    1