BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 8479310 · Received April 3, 2019

    Report

    Report Number
    1221934-2019-56749
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (228151) - LOT NUMBER (L973578) COMBINATION AS PER QLIK QUERY EXECUTED (B)(6)2019. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA CST TOOL THAT THE TRUESPAN 12 DEGREE PEEK MISFIRED. WHEN THE TRIGGER WAS PRESSED THE FIRST ANCHOR DEPLOYED CORRECTLY INTO MENISCUS BUT UPON DEPLOYMENT OF FIRST ANCHOR, SECOND ANCHOR PULLED OUT BEYOND THE SHAFT AND INTO THE NEEDLE. IMPLANTATION OF THAT IMPLANT WAS ABORTED AND ANOTHER TRUESPAN 12 DEGREES WAS USED IN ITS PLACE. THERE WAS A SURGICAL DELAY OF ONE MINUTE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE IMPLANT FROM THE PATIENT AND USING ANOTHER IMPLANT. THERE WERE NO FRAGMENTS GENERATED IN THIS CASE. THE STATUS OF THE PATIENT IS UNKNOWN. THERE WERE NO MEDICAL INTERVENTIONS (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED. IT IS UNKNOWN WHETHER THE PATIENT WAS PART OF A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272393 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SARL L973578 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1