BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 12284952 · Received August 5, 2021

    Report

    Report Number
    3013401747-2021-00051
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 8, 2021
    Report Date
    July 8, 2021
    Manufacturer
    AKROS MEDICAL, INC
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    K162805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART #: FGS-1000, SYNTHES LOT #: 20E027, SUPPLIER LOT #: 20E027, RELEASE TO WAREHOUSE DATE: 18 JAN 2021, EXPIRATION DATE: 12 JAN 2023, SUPPLIER: ROBLING MEDICAL, INC. NO NCR'S GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 AN UNKNOWN PROCEDURE, THE FIBULINK PERMACORD SNAPPED DUE TO ACCIDENTALLY ALLOWING THE SILVER TUBE TO SPIN WITH THE NEEDLE DRIVER. ITEM WAS THEN REMOVED AND A NEW ONE WAS INSERTED. THERE WAS A TWO (2) MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176107 FIBULINK SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN AKROS MEDICAL, INC FGS-1000 20E027 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1