BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTNAIL

    MDR report key: 8839074 · Received July 29, 2019

    Report

    Report Number
    1017294-2019-00104
    Event Type
    Injury
    Date Received
    July 29, 2019
    Report Date
    August 23, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    MAI
    PMA / PMN Number
    K993074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 PREVIOUSLY STATED UNDER CATALOG NUMBER 532445. G5 PREVIOUSLY STATED UNDER 510K NUMBER K031981. ADDITIONAL RESEARCH WAS DONE TO CONFIRM THE PRODUCT NUMBER AND SHIPPING LOCATION AFTER INFORMATION WAS RECEIVED THAT NO PRODUCT WOULD BE RETURNING FOR EVALUATION TO CONFIRM WHICH CATALOG NUMBER WAS USED IN THE PATIENT'S SURGERY. THIS RESEARCH SHOWED THE PREVIOUSLY REPORTED SMARTNAIL CATALOG NUMBER WAS NOT SHIPPED TO THE COUNTRY THAT THE COMPLAINT ORGINATED FROM. ANOTHER CATALOG NUMBER WAS CHOSEN TO BETTER REPRESENT THE PROBABLE DEVICE CATALOG NUMBER BASED ON SHIPPING INFORMATION FOR THE TIME FRAME OF THE SURGERY. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    COMPLAINT IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND ALTHOUGH PHOTOGRAPHS HAVE BEEN PROVIDED, THERE IS NO EVIDENCE OF A BROKEN OFF OR FREE-FLOATING FRAGMENT. THEREFORE, THE REPORTED FAILURE CANNOT BE VERIFIED. DHR WAS UNABLE TO BE REVIEWED DUE TO THE UNAVAILABILITY OF THE LOT NUMBER. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THAT UNTIL HEALING IS COMPLETE, ALL FIXATION ACHIEVED WITH THIS DEVICE SHOULD BE CONSIDERED AS ONLY TEMPORARY AND MAY NOT WITHSTAND WEIGHT-BEARING OR OTHER UNSUPPORTED STRESS. PREMATURE BENDING, LOOSENING, FRACTURE OR MIGRATION OF THE NAILS MAY RESULT FROM EARLY STRESS AND ACTIVITY. APPROPRIATE IMMOBILIZATION/CONTROLLED MOBILIZATION SHOULD BE USED UNTIL CLINICAL DETERMINATION OF HEALING. A SURGEON MUST GIVE THE PATIENT APPROPRIATE INSTRUCTIONS FOR POST-OPERATIVE CARE AND REHABILITATION IN ORDER TO PREVENT PREMATURE LOAD BEARING AND OTHER COMPLICATIONS. PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE NAIL ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. SURGEONS MUST CHOOSE THE PROPER NAIL SIZE BASED ON SPECIFIC PROCEDURE AND PATIENT HISTORY. IMPROPER INSERTION TECHNIQUE MAY CAUSE BREAKAGE OF THE NAIL OR PREMATURE FAILURE. ANY DECISION TO REMOVE THE DEVICE SHOULD TAKE INTO CONSIDERATION THE POTENTIAL RISK TO THE PATIENT OF A SECOND SURGICAL PROCEDURE. NAIL REMOVAL SHOULD BE FOLLOWED BY ADEQUATE POSTOPERATIVE MANAGEMENT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA (B)(6) THAT AFTER SURGERY WITH THE 531516 SMART NAIL, HE HAD CONTINUED PAIN FOR OVER A YEAR. FURTHER INFORMATION WAS RECEIVED ON 7/20/2019 THAT STATED A YEAR AFTER THE INITIAL SURGERY HE RETURNED TO THE HOSPITAL FOR A SECOND SURGERY, THAT THE SMART NAIL HAD MIGRATED INTO THE KNEE. THESE ARE BIOABSORBABLE BUT SINCE IT MIGRATED OUT OF THE ORIGINAL LOCATION, THIS IS A REPORTABLE EVENT DUE TO MIGRATION OF THE IMPLANT REQUIRING A SECOND SURGERY. THE PATIENT'S CURRENT CONDITION IS THAT HE IS STILL IN PAIN FOR UNKNOWN REASONS. THIS REPORT IS BEING RAISED AS A PATIENT INJURY DUE TO A SECONDARY SURGERY THE PATIENT UNDERWENT TO REMOVE FREE FLOATING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633592 SMARTNAIL FIXATION IMPLANT MAI CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other