BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE

    MDR report key: 15261601 · Received August 19, 2022

    Report

    Report Number
    3010667733-2022-00280
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 19, 2022
    Report Date
    October 14, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DELAYED UNION, WHICH REQUIRED REVISION SURGERY, COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE.     IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO PRODUCT CODE AND COMMON DEVICE NAME.

    Description of Event or Problem · 0

    THE POST MARKET CLINICAL TEAM HAS CONDUCTED A FOLLOW-UP REPORT ON ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF SOFT TISSUE RUPTURE OF THE SYNDESMOSIS WITH THE GRAVITY, SYNCHFIX SYNDESMOSIS FIXATION DEVICE¿. THE STUDY WAS CONDUCTED AT COOPER UNIVERSITY HOSPITAL, COOPER BONE AND JOINT INSTITUTE, USA. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 37 PATIENTS. THE CASES IN THE STUDY RANGE FROM JANUARY 1, 2010, TO AUGUST 1, 2021. THE REPORT INDICATES THAT 1 PATIENT EXPERIENCED DELAYED UNION WITH NO BONE CONSOLIDATION, WHICH REQUIRED REVISION SURGERY, UNDERGOING A LEFT ANKLE REMOVAL OF HARDWARE, REVISION OPEN REDUCTION AND INTERNAL FIXATION, AND APPLICATION OF AN EXTERNAL FIXATOR. THE REPORT STATES, ¿THE FIRST DATE OF ADVERSE EVENT OCCURRENCE WAS RECORDED TO BE FIFTY-THREE DAYS AFTER THE INITIAL DATE OF SURGERY. THE ADVERSE EVENT TYPE WAS DELAYED UNION WITH NO BONE CONSOLIDATION WITHIN FOUR MONTHS. IT WAS DETERMINED TO BE A DEVICE-RELATED EVENT IN REGARD TO THE GRAVITY SYNCHFIX DEVICE. THE PATIENT WITH THE ADVERSE EVENT UNDERWENT REVISION SURGERY, UNDERGOING A LEFT ANKLE REMOVAL OF HARDWARE, REVISION OPEN REDUCTION AND INTERNAL FIXATION, AND APPLICATION OF AN EXTERNAL FIXATOR. THE PATIENT WAS WEIGHT-BEARING AND AMBULATORY 4-MONTHS POST-OP, AND SHOWED RADIOGRAPHIC CONSOLIDATION 222 DAYS AFTER THE INITIAL OPERATION¿.

    Description of Event or Problem · 0

    THE POST MARKET CLINICAL TEAM HAS CONDUCTED A FOLLOW-UP REPORT ON ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF SOFT TISSUE RUPTURE OF THE SYNDESMOSIS WITH THE GRAVITY, SYNCHFIX SYNDESMOSIS FIXATION DEVICE¿. THE STUDY WAS CONDUCTED AT COOPER UNIVERSITY HOSPITAL, COOPER BONE AND JOINT INSTITUTE, USA. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 37 PATIENTS. THE CASES IN THE STUDY RANGE FROM JANUARY 1, 2010, TO AUGUST 1, 2021. THE REPORT INDICATES THAT 1 PATIENT EXPERIENCED DELAYED UNION WITH NO BONE CONSOLIDATION, WHICH REQUIRED REVISION SURGERY, UNDERGOING A LEFT ANKLE REMOVAL OF HARDWARE, REVISION OPEN REDUCTION AND INTERNAL FIXATION, AND APPLICATION OF AN EXTERNAL FIXATOR. THE REPORT STATES, ¿THE FIRST DATE OF ADVERSE EVENT OCCURRENCE WAS RECORDED TO BE FIFTY-THREE DAYS AFTER THE INITIAL DATE OF SURGERY. THE ADVERSE EVENT TYPE WAS DELAYED UNION WITH NO BONE CONSOLIDATION WITHIN FOUR MONTHS. IT WAS DETERMINED TO BE A DEVICE-RELATED EVENT IN REGARD TO THE GRAVITY SYNCHFIX DEVICE. THE PATIENT WITH THE ADVERSE EVENT UNDERWENT REVISION SURGERY, UNDERGOING A LEFT ANKLE REMOVAL OF HARDWARE, REVISION OPEN REDUCTION AND INTERNAL FIXATION, AND APPLICATION OF AN EXTERNAL FIXATOR. THE PATIENT WAS WEIGHT-BEARING AND AMBULATORY 4-MONTHS POST-OP, AND SHOWED RADIOGRAPHIC CONSOLIDATION 222 DAYS AFTER THE INITIAL OPERATION¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817507 UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE WASHER, BOLT NUT HTN WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN
    2175925 UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE WASHER, BOLT NUT HTN WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention