BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 12099412 · Received July 1, 2021

    Report

    Report Number
    3013401747-2021-00043
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 9, 2021
    Manufacturer
    AKROS MEDICAL, INC
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. H10 ADDITIONAL NARRATIVE: D4: EXPIRATION DATE G1: MANUFACTURING SITE NAME AND ADDRESS 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 Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. 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 HISTORY LOT - PART #: FGS-1000, SYNTHES LOT #: 20E026, SUPPLIER LOT #: 20E026, RELEASE TO WAREHOUSE DATE: 12 JAN 2021, EXPIRATION DATE: 01 DEC 2023, SUPPLIER: ROBLING MEDICAL, INC, NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW - 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. 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 (B)(6) 2021, PATIENT UNDERWENT A ORIF OF ANKLE. DURING THE PROCEDURE THE SUTURE DEVICE WAS PULLED OUT AND BROKE WHEN INSERTING THE FIBULINK. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES DELAY. 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
    996539 FIBULINK SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN AKROS MEDICAL, INC FGS-1000 20E026 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1