BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAWS STAPLE SYSTEM

    MDR report key: 6966424 · Received October 20, 2017

    Report

    Report Number
    3008650117-2017-00002
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 20, 2017
    Manufacturer
    PARAGON 28, INC.
    Product Code
    JDR
    PMA / PMN Number
    K170923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR STERILE KIT P71-108-0808-S AND LOT 260315217B. THE IMPLANT RECORDS WERE REVIEWED FOR PART P70-108-0008, LOT BDK6TC, BDK65SL, BDLC9WM, BDLC9WN, BDLV7XR, AND EDM-24171. THE IMPLANT WAS MEASURED WITHIN SPEC AND NO MANUFACTURING OR STERILIZATION DEVIATIONS WERE NOTED. THE DHR FOR THE KIT P71-110-1010-S LOT 260317717B WAS ALSO REVIEWED. THE IMPLANT DHRS (B)(4) WERE REVIEWED AS WELL. THE SECOND IMPLANT MEASURED IN SPEC AND NO MANUFACTURING OR STERILIZATION DEVIATIONS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR A BI-LATERAL AKIN PROCEDURE. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. ACCORDING TO THE REPORTER, THE FIRST STAPLE WAS NOT INSERTED FLUSH WITH THE BONE SO A SECOND STAPLE WAS THEN INSERTED. ONE STAPLE BROKE POST OPERATIVELY AFTER BEING IMPLANTED 4 WEEKS. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2017. BOTH STAPLES WERE REMOVED DURING THE REVISION SURGERY. DURING EVALUATION AND INVESTIGATION, THE BROKEN STAPLE X-RAYS WERE EVALUATED AND IT WAS CONFIRMED THAT THE STAPLE WAS BROKEN ALONG THE PROXIMAL, ANGLED ARM. THE PART WAS NOT RETURNED FOR PHYSICAL ANALYSIS. THE DHR FOR THE STERILE KITS WERE REVIEWED AS WELL AS THE MANUFACTURING RECORDS FOR THE IMPLANTS USED IN THE SURGERY. BOTH IMPLANTS WERE MANUFACTURED ACCORDING TO SPECIFICATION WITH NO DEVIATIONS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746523 JAWS STAPLE SYSTEM AKIN STAPLE JDR PARAGON 28, INC. N/A 260315217B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention