BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP IMPACTOR - 3/8-16 INTERFACE

    MDR report key: 20914150 · Received December 12, 2024

    Report

    Report Number
    3013223655-2024-00003
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    September 20, 2024
    Report Date
    November 5, 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

    NO PRODUCT OR PHOTOGRAPH HAS BEEN PROVIDED AND THE COMPLAINT COULD NOT BE CONFIRMED. TWO SIMILAR COMPLAINTS RELATED TO THE TIG WELD FRACTURE HAVE BEEN REPORTED FOR THE SAME LOT. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO ANOMALIES OR NON-CONFORMANCES RAISED. HOWEVER, PHOTOGRAPHS PROVIDED FOR PREVIOUS COMPLAINTS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THR, THE STRIKE PLATE OF A INCIPIO OFFSET CUP IMPACTOR BROKE OFF WHILE IMPACTING THE CUP. IT IS UNKNOWN IF PIECES FELL INTO PATIENT. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A BACK UP. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203042 OFFSET CUP IMPACTOR - 3/8-16 INTERFACE OFFSET CUP IMPACTOR HWA INCIPIO DEVICES 24A0087 07630055304735

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention