BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 8084066 · Received November 19, 2018

    Report

    Report Number
    1221934-2018-55348
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT IS NOT AVAILABLE, THEREFORE NOT APPLICABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS (B)(4), LOT L863136. COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4)-INCOMPLETE. THE EXP DATE IS CURRENTLY UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TRUESPAN IMPLANT DEVICE PULLED OUT OF THE MENISCUS WHEN THE SURGEON PULLED THE THREAD STRONGLY DURING ACL RECONSTRUCTION SURGERY. THE SURGEON FELT THAT THE THREAD WAS NOT SMOOTH COMPARING USUAL. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED TO YOUR SITE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926871 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL L863136 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1