BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 8015961 · Received October 29, 2018

    Report

    Report Number
    1221934-2018-55080
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 8, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE THE DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. WITHOUT PHYSICALLY EVALUATING THE DEVICE, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. NON CONFORMANCE REVIEW WAS PERFORMED, NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER 228151, LOT NUMBER L690034 COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. DEVICE HISTORY LOT: NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER 228151, LOT NUMBER L690034 COMBINATION.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED AS IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED AND AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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

    THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A MENISCAL REPAIR PROCEDURE THE CUSTOMER'S TRUESPAN MENISCAL REPAIR PEEK 12 DEGREE (L690034) FIRED INTO THE MENISCUS BUT THE IMPLANT WOULD NOT HOLD. THE SALES REP STATED THAT THIS SAME ISSUE OCCURRED WITH TWO OTHER TRUESPAN MENSICAL REPAIR PEEK 12 DEGREE (L690034, L991709) AND ONE TRUESPAN MENISCAL REPAIR PEEK 24 DEGREE (L982345). THE SALES REP DID NOT KNOW WHETHER IT WAS THE FIRST OR SECOND IMPLANT OF THE DEVICES THAT HAD THIS MALFUNCTION. THE SALES REP STATED THAT OUT OF THE FOUR DEVICES, TWO IMPLANTS WERE SUCCESSFUL, BUT HE COULD NOT STATE FROM WHICH DEVICES. THE ANCHORS WERE REMOVED WITH A GRASPER WITH NO DEBRIS LEFT BEHIND IN THE PATIENT. THERE WAS A FIVE MINUTE DELAY TO REMOVE THE IMPLANTS. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES WERE DISCARDED BY THE CUSTOMER. 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
    853894 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL L690034 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1