BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROADBAND TAPE

    MDR report key: 19940053 · Received August 8, 2024

    Report

    Report Number
    3006981798-2024-00041
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 5, 2024
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    00810020081176
    PMA / PMN Number
    K100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. THREE RETAINED SAMPLES FROM THE SAME LOT WERE USED TO PERFORM A KNOT PULL TENSILE TEST. THE RETAINED SAMPLES USED FOR THE KNOT PULL TENSILE TEST MET REQUIREMENTS. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE.THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS, AND THE REPORT COULD NOT BE SUBSTANTIATED. A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER: "IT WAS REPORTED THAT INITIAL SURGERY WAS PERFORMED WITH COMPRE REVERSE SYSTEM ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT COMPLAINED OF PAIN IN THE SHOULDER THAT DID NOT GO AWAY. SO SURGEON CHECKED THE X-RAY AND FOUND THAT THE GREATER TUBEROSITY FRAGMENT THAT HAD BEEN SUTURED AT THE INITIAL SURGERY HAD BECOME FREE. PAIN OCCURRED DURING ELEVATION MOVEMENTS, AND A STRANGE NOISE OCCURRED DURING EXTERNAL ROTATION MOVEMENTS. IT IS THOUGHT THAT THE FREE BONE FRAGMENTS MAY BE IMPINGING ON THE IMPLANT OR IN THE JOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069470 BROADBAND TAPE NON ABSORBABLE, UHMWPE SUTURE TAPE GAT RIVERPOINT MEDICAL LLC CM-0322 23062220 00810020081176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other