BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 5352029 · Received January 7, 2016

    Report

    Report Number
    3004976965-2015-00018
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    June 17, 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 BY GREATBATCH MEDICAL. A PROCESS REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. THE DISTRIBUTOR (SMITH & NEPHEW) PERFORMED A VISUAL INSPECTION AND NOTED THAT THE IMPACTOR FAILED AS A RESULT OF WELD FAILURE. SMITH & NEPHEW ALSO NOTED THAT IT WAS LIKELY DUE TO FATIGUE LOADING OF THE WELD JOINT CAUSE BY REPEATED IMPACTS. NO FURTHER INVESTIGATION REQUIRED. (B)(4).

    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 WELDING ON THE INSTRUMENT WAS BEGINNING TO CRACK. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10989 OFFSET CUP IMPACTOR CUP IMPACTOR HWA GREATBATCH MEDICAL OR71368569 13LM18579

    Patients

    Seq Age Sex Outcome Treatment
    1