BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 7523868 · Received May 17, 2018

    Report

    Report Number
    1221934-2018-50668
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    April 17, 2018
    Report Date
    April 17, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY 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. CORRECTION: MFR SITE: THE PHYSICAL MANUFACTURER WAS REPORTED AS DEPUY MITEK LLC US IN THE INITIAL REPORT. IT HAS BEEN UPDATED AS MEDOS INTERNATIONAL SÃ RL. ADDRESS HAS BEEN UPDATED ACCORDINGLY. THE EXPIRATION DATE WAS REPORTED AS UNKNOWN IN THE INITIAL REPORT AND HAS BEEN UPDATED AS 1/31/2020; THEREFORE, UDI:(B)(4). COMPLAINT DEVICE IS NOT BEING RETURNED, MULTIPLES ATTEMPTS FOR PRODUCT RETURN WERE MADE WITH NO RESPONSE, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED.   A DEVICE HISTORY RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4) ¿ INCOMPLETE. THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S TRUE SPAN 12 DEGREE PEEK HAD A STRAIGHT NEEDLE UPON OPENING DURING A MENISCAL REPAIR. THE SALES REP STATED THAT THE NEEDLE SHOULD HAVE BEEN BENT 12 DEGREES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364621 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SARL L272663 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1