BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 5321703 · Received December 22, 2015

    Report

    Report Number
    3004976965-2015-00017
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO GREATBATCH MEDICAL FOR EVALUATION SO THE REPORTED EVENT CANNOT BE CONFIRMED. A PROCESS REVIEW WAS PERFORMED NO DISCREPANCIES FOUND. THE DISTRIBUTOR ((B)(4)) PERFORMED A VISUAL INSPECTION AND NOTED THAT THE IMPACTOR FAILED AS A RESULT OF WELD FAILURE CAUSED BY FATIGUE LOADING OF THE WELD JOINT DUE TO REPEATED IMPACTS. NO FURTHER INVESTIGATION REQUIRED. COMPLAINT INFORMATION WAS PROVIDED BY (B)(4). NOT RETURNED TO GREATBATCH.

    Additional Manufacturer Narrative · 1

    GREATBATCH MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE INNER JOINT BROKE AS CUP WAS IMPACTED. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844291 OFFSET CUP IMPACTOR CUP IMPACTOR HWA GREATBATCH MEDICAL OR71368569 13KM09564

    Patients

    Seq Age Sex Outcome Treatment
    1