BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 22.5 DEG S/SU SLATE BL (5/SP)

    MDR report key: 22802350 · Received August 14, 2025

    Report

    Report Number
    1211998-2025-00013
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 25, 2025
    Report Date
    March 20, 2026
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HNN
    UDI-DI
    50886158000827
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING HANDLING OF A BVI OPTIMUM BLADE (OM NUMBER (B)(6), LOT 6071107), A WAREHOUSE SUPPLY TECHNICIAN SUSTAINED A MINOR CUT FROM A BLADE THAT HAD PARTIALLY PROTRUDED FROM ITS PACKAGING. THE INJURY WAS MINOR AND WAS TREATED WITH A BANDAGE. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT WAS INVOLVED. BVI CONDUCTED AN INVESTIGATION IN ACCORDANCE WITH INTERNAL QUALITY PROCEDURES. THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 6071107, ASSEMBLY AND PACKAGING PROCESS CONTROLS, PACKAGING DESIGN VERIFICATION DOCUMENTATION, AND HISTORICAL COMPLAINT DATA. THE DHR REVIEW CONFIRMED THAT ALL MANUFACTURING AND PACKAGING OPERATIONS WERE COMPLETED IN ACCORDANCE WITH APPROVED PROCEDURES. NO DEVIATIONS, NONCONFORMANCES, CAPAS, OR UNAPPROVED CHANGES WERE IDENTIFIED. PACKAGING DESIGN VERIFICATION TESTING DEMONSTRATED THAT THE PACKAGING CONFIGURATION IS CAPABLE OF ADEQUATELY SECURING THE BLADE DURING STORAGE, HANDLING, AND TRANSPORTATION, INCLUDING FOLLOWING STERILIZATION. A REVIEW OF SIMILAR COMPLAINTS AND HISTORICAL DATA INDICATES THAT THE REPORTED ISSUE IS MOST CONSISTENT WITH ISOLATED BLADE DISPLACEMENT, POTENTIALLY OCCURRING DURING HANDLING OR TRANSPORTATION, RATHER THAN A SYSTEMIC MANUFACTURING OR DESIGN DEFICIENCY. NO SAMPLE WAS RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE IS BLADE DISPLACEMENT OCCURRING AFTER RELEASE FROM MANUFACTURING. THE OVERALL COMPLAINT RATE FOR THIS FAILURE MODE REMAINS WITHIN ACCEPTABLE LIMITS. AT THIS TIME, NO CORRECTIVE OR PREVENTIVE ACTIONS (CAPA) HAVE BEEN INITIATED. THE COMPLAINT HAS BEEN DOCUMENTED, AND TRENDING WILL CONTINUE. APPROPRIATE ACTIONS WILL BE TAKEN IF AN INCREASE IN FREQUENCY OR A TREND IS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A WAREHOUSE SUPPLY TECHNICIAN WAS INJURED BY A SURGICAL BLADE THAT HAD PIERCED THROUGH ITS PACKAGING, RESULTING IN A CUT TO THE TECHNICIAN'S HAND. THE INJURY OCCURRED DURING ROUTINE INVENTORY HANDLING IN THE WAREHOUSE, PRIOR TO CLINICAL USE. A BAND-AID WAS APPLIED, AND NO PATIENT WAS INVOLVED IN THE INCIDENT. ALTHOUGH THE COMPLAINT DOES NOT INDICATE THAT MEDICAL INTERVENTION WAS REQUIRED, THE POTENTIAL FOR SERIOUS INJURY EXISTS IF THIS ISSUE WERE TO RECUR. IT HAS BEEN CONFIRMED THAT NO FURTHER HEALTH COMPLICATIONS OCCURRED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, WE HAVE DETERMINED THAT THIS COMPLAINT MEETS THE CRITERIA FOR REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627384 BLADE 22.5 DEG S/SU SLATE BL (5/SP) BLADE 22.5 DEG S/SU SLATE BL (5/SP) HNN BEAVER-VISITEC INTERNATIONAL, INC. N/A 6071107 50886158000827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other