BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 12044897 · Received June 22, 2021

    Report

    Report Number
    3013401747-2021-00042
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 27, 2021
    Manufacturer
    AKROS MEDICAL, INC
    Product Code
    HTN
    UDI-DI
    00863176000300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H3, H4, H6: PART: (B)(4). SYNTHES LOT: 20E009. SUPPLIER LOT: 20E009. RELEASE TO WAREHOUSE DATE: JULY 13, 2020. SUPPLIER: ROBLING MEDICAL, INC. NO NONCONFORMANCE REPORTS (NCRS) WERE 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. VISUAL INSPECTION: THE FIBULINK® SYNDESMOSIS REPAIR KIT/SS WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION OF THE KIT, THE DRILL BIT WAS BROKEN AT THE TRANSITION POINT OF THE CUTTING FLUTES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO POST MANUFACTURING DAMAGE OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: CURRENT DRAWINGS WERE REVIEWED. - FIBULINK. - 3MM/4MM CANNULATED STEP-DRILL BIT. - TIBIA SCREW AND DRIVER ASSEMBLY. - TIBIA SCREWDRIVER ASSEMBLY. EXACT MANUFACTURING REVISION DRAWINGS COULD NOT BE REVIEWED AS THOSE REVISIONS WERE SOURCE CONTROLLED BY SUPPLIER. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DRILL BIT WAS BROKEN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H6: CODE E2402 USED TO CAPTURE "INJURY." 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. B1, B2 D9 H1, H6 - HEALTH EFFECT - CLINICAL CODE, H6 - HEALTH EFFECT - IMPACT CODE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER NAME AND ADDRESS: REPORTER IS A SYNTHES EMPLOYEE. 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, THE FIBULINK SYNDESMOSIS REPAIR KIT FAILED AND THE CANNULATED DRILL BIT BROKE DURING SURGERY. IT REQUIRED ADDITIONAL INTERVENTION TO REMOVE THE BROKEN FRAGMENTS AND AN ARTHREX TIGHTROPE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THIS REPORT IS FOR ONE (1) FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941091 FIBULINK SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN AKROS MEDICAL, INC FGS-1000 20E009 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention