BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPIPLASTY SYSTEM 2

    MDR report key: 10390694 · Received August 11, 2020

    Report

    Report Number
    3011623994-2020-00023
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 13, 2020
    Report Date
    September 3, 2020
    Manufacturer
    TREACE MEDICAL CONCEPTS, INC.
    Product Code
    HWC
    UDI-DI
    00853114006051
    PMA / PMN Number
    K192504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 08/29/2020: A REVISION SURGERY TO REMOVE ALL HARDWARE WAS SUCCESSFULLY COMPLETED ON (B)(6) 2020. UPON REMOVAL, IT WAS CONFIRMED THAT ONE SCREW WAS BROKEN. NO ADDITIONAL DEVICE DEFICIENCIES WERE FOUND. THE SURGEON USED BIOLOGIC AND A STAPLE VERSUS REPLACING THE HARDWARE AS THE PATIENT'S BONES WERE PLANTARLY FUSED. UPDATED DATA: B5: IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ONE SCREW WAS FOUND BROKEN UPON REVIEW OF RADIOGRAPHIC IMAGES FROM THE PATIENTS POSTOPERATIVE FOLLOW-UP. A REVISION SURGERY TO REMOVE ALL HARDWARE WAS SUCCESSFULLY COMPLETED ON (B)(6) 2020. UPON REMOVAL, NO ADDITIONAL DEVICE DEFICIENCIES WERE FOUND. THE SURGEON USED BIOLOGIC AND A STAPLE VERSUS REPLACING THE HARDWARE AS THE PATIENT'S BONES WERE PLANTARLY FUSED. H1: TYPE OF REPORTABLE EVENT - SERIOUS INJURY. H3: DEVICE WAS NOT EVALUATED BY THE MANUFACTURER AS IT WAS NOT RETURNED FOR EVALUATION. NEW INFORMATION: B2: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) B4: DATE OF THIS REPORT - 09/03/2020. D7: EXPLANTED ON (B)(6) 2020. G4: NEW INFORMATION RECEIVED BY MANUFACTURER ON 08/29/2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ONE SCREW WAS FOUND BROKEN UPON REVIEW OF RADIOGRAPHIC IMAGES FROM THE PATIENTS POSTOPERATIVE FOLLOW-UP. A REVISION SURGERY TO REMOVE ALL HARDWARE WAS SUCCESSFULLY COMPLETED ON (B)(6) 2020. UPON REMOVAL, NO ADDITIONAL DEVICE DEFICIENCIES WERE FOUND. THE SURGEON USED BIOLOGIC AND A STAPLE VERSUS REPLACING THE HARDWARE AS THE PATIENT'S BONES WERE PLANETARY FUSED.

    Additional Manufacturer Narrative · 1

    AFTER AN INITIAL BUNION SURGERY, IT WAS REPORTED THAT ONE SCREW WAS FOUND BROKEN UPON REVIEWING RADIOGRAPHIC IMAGES FROM A ROUTINE FOLLOW-UP APPOINTMENT. THE DEVICE CURRENTLY REMAINS IMPLANTED WITH A REVISION SCHEDULED FOR (B)(6) 2020. THE DEVICE HISTORY RECORDS FOR ALL DEVICES INTENDED TO BE IMPLANTED WERE REVIEWED (SK14, 1405-1408, 1405-1409, AND 1405-4051) AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURE AND RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO WHAT WAS REPORTED. ALTHOUGH A NUMBER OF FACTORS COULD HAVE CONTRIBUTED TO THE BREAKAGE OF THE SCREW, IT IS POSSIBLE THE INITIAL PLACEMENT OF THE PLATES COMBINED WITH THE PATIENT'S NON-COMPLIANCE AND RESULTING NON-UNION LIKELY SUBJECTED EXCESSIVE STRESS TO THE SCREW. THE INSTRUCTIONS FOR USE IDENTIFY WARNINGS RELATED TO POSTOPERATIVE CARE. THE COMPANY WILL SUPPLEMENT THE MDR AS NECESSARY AND APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ONE SCREW WAS FOUND BROKEN UPON REVIEW OF RADIOGRAPHIC IMAGES FROM THE PATIENTS POSTOPERATIVE FOLLOW-UP. THE DEVICES CURRENTLY REMAIN IMPLANTED WITH REVISION SCHEDULED FOR (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854611 LAPIPLASTY SYSTEM 2 SCREW HWC TREACE MEDICAL CONCEPTS, INC. SK14 26996 00853114006051

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention