BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLENGER SWIVEL KNIFE BAY 4MM

    MDR report key: 10988593 · Received December 10, 2020

    Report

    Report Number
    2523190-2020-00146
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 11, 2020
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KTG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI) - (B)(4). THE BALLENGER SWIVEL KNIFE WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: UPON VISUAL INSPECTION, THE RETURNED PRODUCT IS IN USED CONDITION WITH THE TIP BROKEN OFF/DAMAGED. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY WAS OBSERVED. ROOT CAUSE: THE REPORTED COMPLAINT IS CONFIRMED. THE RETURNED SWIVEL KNIFE IS IN USED CONDITION WITH THE TIP BROKEN OFF. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A FACILITY REPORTED THE SWIVEL KNIFE BROKE IN THE PATIENTS' NASAL CAVITY DURING PROCEDURE (SEPTOPLASTY AND BILATERAL TURBINATE REDUCTION). THE PHYSICIAN WAS ABLE TO RETRIEVE THE SMALL BROKEN PIECE THAT BROKE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447276 BALLENGER SWIVEL KNIFE BAY 4MM N/A KTG INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1