BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXBRIDGE AFN CORTICAL SCREW

    MDR report key: 10501827 · Received September 8, 2020

    Report

    Report Number
    3008951116-2020-00006
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    May 18, 2020
    Report Date
    September 8, 2020
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HWC
    PMA / PMN Number
    K121575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS NOT AVAILABLE FOR FURTHER ANALYSIS AND IT WAS NOT POSSIBLE TO DETERMINE THE ROOT OF THE REPORTED SCREW FRACTURE AS PART OF THIS INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE PRODUCT WAS SUPPLIED IN CONFORMANCE WITH STRINGENT ORTHO SOLUTIONS SPECIFICATIONS. THE PRODUCTS HAVE FULL TRACEABILITY THROUGH THE MANUFACTURING PROCESS TO THE RAW MATERIAL, AND THE PRODUCT PASSED ALL OF THE BATCH RELEASE VERIFICATION WITHOUT ANY DEVIATIONS. THE RAW MATERIAL FOR THE COMPLAINT PRODUCT IS ASTM F136 TI-6AL-4V, WHICH IS A LONG ESTABLISHED AND WIDELY USED IMPLANT GRADE MATERIAL THAT IS CONSISTENT WITH THE TECHNOLOGICAL STATE-OF-THE-ART. USING THE PIVOTAL DATASETS FROM THE CLINICAL EVALUATION REPORT, THE OVERALL CALCANEAL SCREW FRACTURE RATE REPORTED IN THE SCIENTIFIC LITERATURE FOR THE EQUIVALENT DEVICES WAS 2.9%. THE FAILURE RATE OF 0.24 % ASSOCIATED WITH THIS COMPLAINT THEREFORE COMPARES FAVOURABLY, AND THE OXBRIDGE¿ AFN CONTINUES TO BE CLINICALLY SAFE AND WELL PERFORMING. CALCANEAL SCREW FRACTURE IS A KNOWN RESIDUAL CLINICAL RISK FOR TIBIOTALOCALCANEAL ARTHRODESIS, AND THIS RISK HAS BEEN REDUCED FOR THE OXBRIDGE¿ AFN AS FAR AS POSSIBLE. BASED ON THE PRODUCT FAILURE RATE AND THE RESULTS FROM THE INVESTIGATIONS CONDUCTED, THERE ARE CURRENTLY NO CORRECTIVE ACTIONS TO BE TAKEN. THIS COMPLAINT WILL HOWEVER BE MONITORED THROUGH ORTHO SOLUTION'S POST MARKET SURVEILLANCE PROCEDURES FOR RE-OCCURRENCE AND ANY EVIDENCE OF NEGATIVE TREND.

    Description of Event or Problem · 1

    THE PATIENT HAD UNDERGONE TTC FUSION EARLIER IN THE YEAR ON (B)(6) 2020, AND UPON ROUTINE X-RAY FOLLOW-UP ON (B)(6) 2020, IT WAS OBSERVED THAT THE CALCANEAL SCREW HAD FRACTURED, AT THE POINT WHERE IT ENTERS THE INTRAMEDULLARY NAIL. THE PATIENT IS DIABETIC, AND STARTED PARTIAL WEIGHT-BEARING IN A BOOT AT 6-WEEKS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970238 OXBRIDGE AFN CORTICAL SCREW OXBRIDGE AFN 5.0MM X 65MM CORTICAL SCREW HWC ORTHO SOLUTIONS UK LTD OS330065 11716916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other