BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 12374529 · Received August 26, 2021

    Report

    Report Number
    3013401747-2021-00056
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    August 22, 2021
    Report Date
    August 22, 2021
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    K162805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. D4 H3, H4, H6: PART # FGS-1000 SYNTHES LOT # 20E011 SUPPLIER LOT # (B)(4) RELEASE TO WAREHOUSE DATE: 22JUL2020 EXPIRATION DATE: 01JUL2023 SUPPLIER: (B)(4) NO 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. 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.

    Additional Manufacturer Narrative · 1

    PART # FGS-1000, SYNTHES LOT # 20E011, SUPPLIER LOT # 20E011, RELEASE TO WAREHOUSE DATE: 22JUL2020, EXPIRATION DATE: 01JUL2023, SUPPLIER: ROBLING MEDICAL, INC. NO 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON PERFORMED AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF BILMALLEOLAR ANKLE FRACTURE WITH SYNDESMOTIC INJURY. AFTER USING A SYNTHES VA LCP DISTAL FIBULA PLATE TO REPAIR FIBULA FRACTURE, AND TWO CANNULATED SCREWS TO REPAIR THE MEDIAL MALLEOLUS. SURGEON THEN USED A LARGE TENACULUM TO REDUCE THE SYNDESMOSIS INJURY AND BEGAN PREPARING THE BONE FOR THE FIBULINK FOLLOWING THE SURGICAL TECHNIQUE. ONCE THE SURGEON INSERTED THE TIBIA SCREW TO THE CORRECT DEPTH THE INDICATOR GROOVE WAS VISIBLE JUST LATERAL TO THE PLATE AND A STANDARD TENSIONING CAP WAS USED. THE SURGEON SECURED A CLAMP TO THE SILVER TUBE AND PULLED LATERALLY AND ENGAGED THE TENSIONING CAP WITH THE LINK BY TURNING THE CLAMP CLOCKWISE. THE CAP DID ENGAGE THE FIBULINK BUT WOULD NOT TIGHT TO THE DEGREE THAT IT MAINTAINED REDUCTION OF THE SYNDESMOSIS INJURY. AFTER ATTEMPTING TO TIGHTEN THE TENSIONING CAP FOR SEVERAL MINUTES, WHILE ENSURING LATERAL TENSION ON SILVER TUBE TO PREVENT ROTATION I SUGGESTED THAT THE SURGEON PULL BACK SLIGHTLY ON THE TENSIONING KNOB. ONCE THE SURGEON PULLED BACK ON TENSIONING KNOB IT DISENGAGED FROM THE TENSIONING CAP. UNSUCCESSFUL ATTEMPTS WERE MADE TO REATTACH THE TENSIONING KNOB TO THE CAP. FOLLOWING THESE ATTEMPTS THE SURGEON DECIDED HE WOULD LIKE TO REMOVE THE DEVICE COMPLETELY. THE FIBULA TENSIONING CAP REMOVER WAS USED TO SUCCESSFULLY REMOVE THE CAP. THE LINK, SUTURE AND TIBIA SCREW REMAINED IN THE PATIENT. HE USED THE FIBULA LINK AND TIBIA SCREW REMOVER AND ATTEMPTED TO REMOVE THE LINK AND TIBIA SCREW HOWEVER THE DRIVER WOULD NOT ENGAGE INTO THE HEXALOBE OF THE TIBIA SCREW. THE SURGEON ALSO USED A TIBIA SCREW REMOVER WHICH DID NOT WORK EITHER. AFTER MANY ATTEMPTS TO REMOVE THE LINK AND TIBIA SCREW, THE SURGEON DECIDED HE WOULD LEAVE THE DEVICE IN PATIENT AS TRYING TO REMOVE IT MAY CAUSE UNWANTED DAMAGE. THE SURGEON THEN USED A TIGHT ROPE TO COMPLETE THIS PART OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 30 MINUTES SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN VA-LCP DISTAL FIBULA PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN CANNULATED SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271056 FIBULINK SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN WRIGHTS LANE : SYNTHES USA PRODUCTS LLC FGS-1000 20E011 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR FIBULINK® REMOVAL KIT| FIBULINK® SYNDESMOSIS REPAIR KIT/SS| UNK - PLATES: VA-LCP FIBULA| UNK - SCREWS: CANNULATED