BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMC SPEEDMTP

    MDR report key: 21749227 · Received April 1, 2025

    Report

    Report Number
    3011623994-2025-00031
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 4, 2025
    Report Date
    May 1, 2025
    Manufacturer
    TREACE MEDICAL CONCEPTS, INC.
    Product Code
    JDR
    UDI-DI
    00810111223508
    PMA / PMN Number
    K242415
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO THE PLATE LIFTING OUT OF THE BONE. AN X-RAY DETECTED THAT THE PLATE WAS PLACED TOO PROXIMAL AND THIS ONLY ALLOWED ONE POINT OF FIXATION OF THE DISTAL END. IN ADDITION, A SCREW APPEARED TO FRACTURE THROUGH THE BASE OF THE PROXIMAL PHALANX ADDING TO THE OVER ALL INSTABILITY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE SPECIFIC INFORMATION WAS NOT AVAILABLE; THEREFORE, A REVIEW OF DEVICE HISTORY RECORDS WAS NOT ABLE TO BE PERFORMED. HOWEVER, ALL NON-CONFORMANCES FOR POSSIBLE KITS UTILIZED IN SURGERY WERE REVIEWED AND NO NON-CONFORMANCES OR ISSUES DURING THE MANUFACTURE OR RELEASE OF THE PRODUCTS WERE IDENTIFIED TO DATE THAT COULD HAVE CONTRIBUTED TO WHAT WAS REPORTED. ALTHOUGH SEVERAL FACTORS CAN CONTRIBUTE TO THE REPORTED EVENT, THE MOST LIKELY CAUSE CANNOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED, AND NO DEVICE BEING RETURNED. HOWEVER, ADDITIONAL INFORMATION INDICATES THAT OPERATOR TECHNIQUE MAY HAVE CONTRIBUTED TO WHAT THE PATIENT EXPERIENCED. THE COMPANY WILL SUPPLEMENT THIS MDR AS NECESSARY AND APPROPRIATE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D1: BRAND NAME: TMC SPEEDMTP; D4: MODEL NUMBER: SK58; LOT NUMBER: 300599184; EXPIRATION DATE: 10-23-2029; UDI: (B)(4); D6A: IMPLANT DATE: (B)(6) 2024; G3: DATE RECEIVED BY MANUFACTURER: 04-02-2025; G4: 510K: K242415 ; H2: IF FOLLOW-UP, WHAT TYPE: ADDITIONAL INFORMATION; H4: MANUFACTURE DATE: 10-23-2024. H11: IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO THE PLATE LIFTING OUT OF THE BONE. AN X-RAY DETECTED THAT THE PLATE WAS PLACED TOO PROXIMAL AND THIS ONLY ALLOWED ONE POINT OF FIXATION OF THE DISTAL END. IN ADDITION, A SCREW APPEARED TO FRACTURE THROUGH THE BASE OF THE PROXIMAL PHALANX ADDING TO THE OVER ALL INSTABILITY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE SPECIFIC INFORMATION WAS NOT AVAILABLE; THEREFORE, A REVIEW OF DEVICE HISTORY RECORDS WAS NOT ABLE TO BE PERFORMED. HOWEVER, ALL NON-CONFORMANCES FOR POSSIBLE KITS UTILIZED IN SURGERY WERE REVIEWED AND NO NON-CONFORMANCES OR ISSUES DURING THE MANUFACTURE OR RELEASE OF THE PRODUCTS WERE IDENTIFIED TO DATE THAT COULD HAVE CONTRIBUTED TO WHAT WAS REPORTED. ALTHOUGH SEVERAL FACTORS CAN CONTRIBUTE TO THE REPORTED EVENT, THE MOST LIKELY CAUSE CANNOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED, AND NO DEVICE BEING RETURNED. HOWEVER, ADDITIONAL INFORMATION INDICATES THAT OPERATOR TECHNIQUE MAY HAVE CONTRIBUTED TO WHAT THE PATIENT EXPERIENCED. THE COMPANY WILL SUPPLEMENT THIS MDR AS NECESSARY AND APPROPRIATE. ADDITIONAL TMC DEVICE EXPLANTED IN THE SAME REVISION SURGERY WAS REPORTED IN 3011623994-2025-00041.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO THE PLATE LIFTING OUT OF THE BONE. AN X-RAY DETECTED THAT THE PLATE WAS PLACED TOO PROXIMAL AND THIS ONLY ALLOWED ONE POINT OF FIXATION OF THE DISTAL END. IN ADDITION, A SCREW APPEARED TO FRACTURE THROUGH THE BASE OF THE PROXIMAL PHALANX ADDING TO THE OVER ALL INSTABILITY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713229 TMC SPEEDMTP STAPLE JDR TREACE MEDICAL CONCEPTS, INC. SK58 300599184 00810111223508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention