BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURIST

    MDR report key: 7403094 · Received April 6, 2018

    Report

    Report Number
    3009611746-2018-00002
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    July 5, 2017
    Report Date
    March 9, 2018
    Manufacturer
    JOSSI AG
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR NOTIFIED THE MANUFACTURER THAT ONE SURGEON IN (B)(6), NEW TO THE USE OF PURIST DEVICE HAS EXPERIENCED A HIGHER THAN EXPECTED NUMBER OF FIBULA FACTURES WITH THE USE OF THE DEVICE THAT HE BELIEVES MAY THAT THE PURIST DEVICE MAY HAVE CONTRIBUTED. FRACTURES ARE AN ANTICIPATED LOW FREQUENCY POTENTIAL COMPLICATION FOR THIS TYPE OF SURGERY. THIS SURGEON EXPERIENCED 3 FIBULA FRACTURES IN 400 CASES WHEREAS A MORE TYPICAL FREQUENCY BASED ON EXPERIENCE IN U.S. AND EUROPE OF LESS THAN 0.2%. EACH PATIENT HAD POROUS BONES. THE FRACTURES WERE NON-DISPLACED AND REQUIRED NO ADDITIONAL TREATMENT. MANUFACTURER'S REPRESENTATIVES FOLLOWED UP WITH THE SURGEON AND SITE TO CONFIRM THAT THE DEVICE WAS IN GOOD WORKING ORDER AND TO FURTHER EDUCATE THE SITE ON THE BEST APPROACH FOR PREPARATION OF THE FOOT WHEN IT IS INSERTED INTO THE BOOT ATTACHMENT INCLUDING THE USE OF THE CORRECT SIZE BOOT TO MINIMIZE THE RISK OF FIBULA FRACTURE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THE FOLLOWING: " I NEED TO REPORT ON 3 PATIENTS OVER THE PAST 12 MONTHS WHO HAVE HAD FIBULA FRACTURES USING THE PURIST AND BOOT. THE PROBLEM IS THAT THE BOOT DOES NOT ALLOW A REALLY TIGHT FIT AROUND THE ANKLE WHICH MEANS THAT WHEN EXTERNALLY ROTATING THE LEG SOME OF THAT ROTATION IS OCCURRING AT THE ANKLE JOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245573 PURIST LEG POSITIONING SYSTEM FWZ JOSSI AG

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention