BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 11602859 · Received April 1, 2021

    Report

    Report Number
    3013401747-2021-00028
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 5, 2021
    Manufacturer
    AKROS MEDICAL, INC
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    K162805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H6: PART: FGS-1000 SYNTHES LOT: 20E026 SUPPLIER LOT: N/A RELEASE TO WAREHOUSE DATE: JANUARY 12, 2021 EXPIRATION DATE: N/A SUPPLIER: ROBLING MEDICAL INC. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. D1.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE WITH THE FIBULINK SYNDESMOSIS REPAIR KIT, THE SURGEON PULLED LATERALLY, AND THE SUTURE SNAPPED. THERE WERE NO FRAGMENTS GENERATED. A NEW FIBULINK WAS INSERTED AND SYNDESMOSIS WAS STABLE. THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) FIBULINKÂ SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500614 FIBULINK SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN AKROS MEDICAL, INC FGS-1000 20E026 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1