BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING T-HANDLE A/O & TRI-LOBE QR

    MDR report key: 18598971 · Received January 29, 2024

    Report

    Report Number
    3025141-2022-00319
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Report Date
    January 29, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH/LOT NUMBER OF THE DEVICE WAS RECEIVED ON 20 JANUARY 2024. THEREFORE, MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE NOTED. THE DEVICE STILL HAS NOT BE RECEIVED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: TYPE OF INVESTIGATION CODE (ANNEX B) UPDATED TO 3331.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE 80-0999 RATCHETING T-HANDLE A/O & TRI-LOBE QR "DISINTEGRATED WITH THE BALL BEARINGS EVERYWHERE". ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT (EVENT DATE, IF THIS OCCURRED DURING A PROCEDURE, PATIENT IMPACT, ETC.) HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142765 RATCHETING T-HANDLE A/O & TRI-LOBE QR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0999 407945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown