BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS NITINOL STAPLE SYSTEM

    MDR report key: 10858288 · Received November 18, 2020

    Report

    Report Number
    3008650117-2020-00161
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    July 12, 2019
    Report Date
    November 17, 2020
    Manufacturer
    PARAGON 28, INC.
    Product Code
    JDR
    PMA / PMN Number
    K170923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES ARE NOT EXPECTED TO BE RETURNED FOR THE MANUFACTURER REVIEW/INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND MET ALL MATERIAL SPECIFICATIONS WITH NO DEVIATION IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MTP FUSION SURGICAL PROCEDURE ON (B)(6) 2019 THAT UTILIZED PARAGON 28 JAWS NITINOL STAPLE SYSTEM. THE 18 X 18MM STRAIGHT STAPLE ASSEMBLY WAS REPORTED TO HAVE BROKEN 6 WEEKS POST-OPERATIVELY. THE PATIENT WAS NON-WEIGHT BEARING AND FOLLOWED THE SURGEON'S POST-OPERATIVE INSTRUCTION. THE SURGEON REPORTED THAT THE PATIENT'S CAST IS PRISTINE AND THAT THE DISUSE OSTEOPENIA CONFIRMS ADHERENCE TO NON-WEIGHT BEARING INSTRUCTIONS. THERE WAS NO REVISION SURGERY REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330476 JAWS NITINOL STAPLE SYSTEM BONE STAPLE JDR PARAGON 28, INC. P71-018-1818-S 260316219B

    Patients

    Seq Age Sex Outcome Treatment
    1