BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28, 2.5MM DIAMETER LOCKING SCREW

    MDR report key: 5809710 · Received July 20, 2016

    Report

    Report Number
    3011623994-2016-00012
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Report Date
    February 22, 2017
    Manufacturer
    TREACE MEDICAL CONCEPTS, INC.
    Product Code
    HWC
    UDI-DI
    0853114006006
    PMA / PMN Number
    K143717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 28MM, 2.5MM DIAMETER LOCKING SCREW (1405-1028) IS PROVIDED TO CUSTOMERS ASSEMBLED (1405-4007, DIAMETER 2.5MM LOCKING SCREW X 28MM WITH WASHER) WITHIN A STERILE KIT (SK-12) AND MARKED SINGLE USE. THE UDI REFERENCED IS FOR THE STERILE KIT, SK-12, THAT THE PRODUCT IS DISTRIBUTED WITHIN. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINS IMPLANTED AND BASED ON INFORMATION FROM THE SURGEON, THERE ARE NO PLANS TO REVISE. THE DHR REVIEW IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED. THE COMPANY WILL SUPPLEMENT THIS MDR AS NECESSARY AND APPROPRIATE. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE 28MM, 2.5MM DIAMETER LOCKING SCREW (1405-1028) IS PROVIDED TO CUSTOMERS ASSEMBLED (1405-4007, DIAMETER 2.5MM LOCKING SCREW X 28MM WITH WASHER) WITHIN A STERILE KIT (SK-12) AND MARKED SINGLE USE. THE UDI REFERENCED IS FOR THE STERILE KIT, SK-12, THAT THE PRODUCT IS DISTRIBUTED WITHIN. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINS IMPLANTED AND BASED ON INFORMATION FROM THE SURGEON, THERE ARE NO PLANS TO REVISE. THE DHR REVIEW COMPLETED FOR TWO POSSIBLE LOTS (15223 OR HG15204) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED. THE RADIOGRAPHIC EVIDENCE SUBMITTED WITH THE COMPLAINT WAS RE-REVIEWED ON (B)(6) 2017 AND IT WAS DETERMINED THAT THE ROOT CAUSE OF THE SCREW BREAKING IS MOST LIKELY A RESULT OF NON-UNION OF THE PATIENT'S BONE AFTER SURGERY DUE TO SCREWS BEING PLACED IN AREAS AND/OR USING A TECHNIQUE WHERE FUSION IS NOT LIKELY TO OCCUR. THE DEVICE IS INTENDED FOR FUSION AND NON-UNION IS A KNOWN POTENTIAL ADVERSE EVENT IDENTIFIED IN THE INSTRUCTIONS FOR USE, LBL 1405-9005 PROVIDED WITH THE STERILE KIT. THE COMPANY WILL SUPPLEMENT THIS MDR AS NECESSARY AND APPROPRIATE.

    Description of Event or Problem · 1

    DURING A STANDARD POST OPERATIVE FOLLOW UP VISIT, IT WAS NOTICED BY THE SURGEON THAT THE 28MM SCREW (1405-1028) HAD BROKEN. THE SCREW HAD ORIGINALLY BEEN PLACED IN A LAPIDUS PROCEDURE ON (B)(6) 2015 FROM THE BASE OF THE 1ST TO THE 2ND METATARSALS. THE SCREW WAS NOT SYMPTOMATIC AND THE PATIENT HAS RETURNED TO FULL ACTIVITY. IN ADDITION, THE TMT (TARSOMETATARSAL) JOINT WAS FULLY FUSED/HEALED. THERE WAS NO REPORTED PATIENT IMPACT AS A RESULT OF THE BROKEN SCREW AND NO PLANS FOR REVISION BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464150 28, 2.5MM DIAMETER LOCKING SCREW SCREW HWC TREACE MEDICAL CONCEPTS, INC. 1405-1028 0853114006006

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR