BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø11X360 MM X 125°

    MDR report key: 7710515 · Received July 23, 2018

    Report

    Report Number
    0009610622-2018-00373
    Event Type
    Injury
    Date Received
    July 23, 2018
    Date of Event
    January 1, 2014
    Report Date
    July 23, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    07613153316961
    PMA / PMN Number
    K032898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES IMPLANT BREAKAGE. TWO (CASE ID 62) OUT OF 3 CASES. THE PMCFR STATES: ¿IN 3 CASES (CASE 20,62 AND 71) BREAKAGE OF THE MATERIAL OCCURRED. THE BREAKAGE WAS SITUATED ON THE LOCKING SCREWS AND NEVER ON THE NAIL ITSELF. IN THE SECOND CASE (CASE 62) IT WAS A TRANSVERSE FRACTURE (32-A) IN A HEAVY 70 YEARS LADY. SHE IS 1,63M IN HEIGHT FOR A WEIGHT OF (B)(6). THE BREAKAGE OF ALL THREE LOCKING SCREWS WAS OBSERVED. IN FACT A SEPTIC NONUNION WAS OBSERVED AND A REVISION SURGERY WAS PERFORMED 142 DAYS AFTER THE INITIAL SURGERY. ALL THE BROKEN SCREWS WERE REMOVED (18965050S-K05D869; 18965050S-K0AF9E2; 18965042S-K074FFC), THE NAIL WAS ALSO REMOVED (18471136S-K0DADEB) THE MEDULLARY CANAL WAS REAMED AND A T2 A/R NAIL WAS THEN USED. ANTIBIOTICS WERE USED DURING 4 MONTHS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552603 RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø11X360 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0DADEB 07613153316961

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention