BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCIPIO OFFSET CUP IMPACTOR - 3/8-16 INTERFACE

    MDR report key: 20915083 · Received December 12, 2024

    Report

    Report Number
    3013223655-2024-00001
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    September 5, 2024
    Report Date
    November 1, 2024
    Manufacturer
    INCIPIO DEVICES
    Product Code
    HWA
    UDI-DI
    07630055304735
    Removal / Correction Number
    95653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. PHOTOGRAPHS OF THE DEVICE CONFIRMED THE REPORTED PRODUCT ISSUE. THE TIG WELD HAS PARTIALLY FRACTURED. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO ANOMALIES OR NONCONFORMANCES FOUND. HOWEVER, PHOTOGRAPHS PROVIDED FOR OTHER COMPLAINTS ON THIS PRODUCT LOT APPEARED TO SHOW AN ANOMALY WITH REGARDS TO THE TIG WELD QUALITY. INVESTIGATION DEMONSTRATED THAT THE ISSUE WAS CAUSED BY INADEQUATE OPERATOR TECHNIQUE DURING THE TIG WELD OPERATION. QUALIFICATION RECORDS FOR THE WELDERS ARE ON RECORD. EXTERNAL TRAINING COURSES HAVE BEEN SCHEDULED. THE EFFECTIVENESS OF THE TRAINING WILL BE TESTED BY THE EXTERNAL TRAINING FIRM. OWING TO THE HIGH LIKELIHOOD OF FAILURE FOR THIS PRODUCT LOT, A RECALL FOR THIS PRODUCT LOT HAS BEEN INITIATED. NO PATIENT HARM RESULTED FROM THIS MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) INCIPIO R3 OFFSET CUP IMPACTOR CRACKED WHILE IMPACTING THE CUP. THE PROCEDURE RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164582 INCIPIO OFFSET CUP IMPACTOR - 3/8-16 INTERFACE INCIPIO OFFSET CUP IMPACTOR HWA INCIPIO DEVICES 24A0087 07630055304735

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention