BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PATXRAY 1/2X1/2-200

    MDR report key: 17483732 · Received August 8, 2023

    Report

    Report Number
    3014334038-2023-00131
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 25, 2023
    Report Date
    May 24, 2024
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    UDI-DI
    10381780514961
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H6, H11 THE SURGICAL PATTY (ID 801400) WAS NOT RETURNED FOR EVALUATION, BUT A PHOTO WAS PROVIDED SHOWING THE GREEN STRING DETACHED. THEREFORE, THE COMPLAINT IS CONFIRMED. ROOT CAUSE - POTENTIAL ROOT CAUSES INCLUDE INSUFFICIENT STRING STRENGTH, MATERIAL THICKNESS VARIATION, ENVIRONMENTAL CONDITIONS, IMPROPER WELDING PARAMETERS, OR USER MISUSE. THERE IS CURRENTLY AN OPEN CORRECTIVE AND PREVENTATIVE ACTION (CAPA) FOR THE PATTIES/STRIPS PRODUCT FAMILY RELATED TO STRING ISSUES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H4, H10. THE SURGICAL PATTY (ID 801400) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED A SURGICAL PATTY (ID (B)(4) ) DETACHED FROM THE STRING WHILE IN PATIENT. THE PATTIES WERE MOISTENED 30 MINUTES PRIOR TO USE, IRRIGATED DURING USE AND THE PRODUCT WAS NOT ALTERED OR CUT FROM THE ORIGINAL SIZE PRIOR TO USE. THERE WAS A 30-MINUTE SURGICAL DELAY DUE TO SEARCH FOR MISSING PATTY AND NEEDING TO OBTAIN X-RAY TO RULE OUT BEING IN PATIENT. SURGERIES BEING PERFORMED WERE C3-C7 DECOMPRESSIVE LAMINECTOMIES AND C2-T1 POSTERIOR CERVICAL FUSION WITH DEPUY SYMPHONY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344027 SURG PATXRAY 1/2X1/2-200 SURGICAL PATTIES HBA RAYNHAM 6560987 10381780514961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown