BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 7921286 · Received September 30, 2018

    Report

    Report Number
    1221934-2018-54780
    Event Type
    Malfunction
    Date Received
    September 30, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 31, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 EVALUATION STATEMENT: THE DEVICE IS NOT BEING RETURNED. THE DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION AND HENCE THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (228151), LOT(L790017) COMBINATION AND NO NONCONFORMANCES WERE FOUND. 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. UDI: (B)(4). ASSOCIATED MEDWATCH REPORT NUMBER: 1221934-2018-54779.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A MENISCAL REPAIR PROCEDURE THE CUSTOMER'S TRUESPAN MENISCAL REPAIR PEEK 12 DEGREE DID NOT DEPLOY THE FIRST IMPLANT. THE CUSTOMER OPENED A SECOND TRUESPAN MENISCAL REPAIR PEEK 12 DEGREE AND BOTH IMPLANTS FIRED, BUT PULLED OUT AND DID NOT STAY IN THE BONE. THE IMPLANTS WERE REMOVED AND THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH A THIRD-LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM, BUT A FIVE MINUTE DELAY TO OPEN NEW DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762248 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SARL L790017 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1