BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 24 DEGREE PEEK

    MDR report key: 10080204 · Received May 21, 2020

    Report

    Report Number
    1221934-2020-01422
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 8, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705026029
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (5L80094), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (5L80094), AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL NARRATIVE: UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION THAT DURING A MENISCAL SUTURING WHEN THE SURGEON TRIED TO PULL THE TRIGGER OF ATRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE, S/HE FELT TIGHT ON THE TRIGGER. WHEN THE TRIGGER WAS PULLED, IT CLICKED AND BROKE (BECAME WOBBLY). WITHOUT DEPLOYING THE 1ST IMPLANT, THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE DEVICE IS NOT AVAILABLE FOR RETURN AND INFORMATION REGARDING THE EVENT COULD NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541869 TRUESPAN 24 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL 228152 5L80094 10886705026029

    Patients

    Seq Age Sex Outcome Treatment
    1