BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 5351991 · Received January 7, 2016

    Report

    Report Number
    3004976965-2015-00021
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    April 7, 2015
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    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 AND NO DISCREPANCIES WERE FOUND. THE CUSTOMER (SMITH & NEPHEW) CONCLUDED THAT FRACTURE OCCURRED DUE TO A STATIC OR FATIGUE FAILURE MECHANISM. NO FURTHER INVESTIGATION REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM CUSTOMER WAS RECEIVED WHICH IDENTIFIED THE DEVICE MANUFACTURING SITE. THE MANUFACTURER REGISTRATION NUMBER FOR THE MANUFACTURING SITE WAS (B)(4). UPDATED MANUFACTURING SITE TO GREATBATCH (B)(4).. UPDATED MANUFACTURING SITE TO GREATBATCH (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

    THE GEAR MECHANISM OF THE OFFSET CUP IMPACTOR SNAPPED OR SHEARED OFF WHILE IMPACTING THE TRIAL CUP. THE STRAIGHT INTRODUCER WAS USED TO GET THE IMPLANT IMPACTED. NO ADVERSE EVENTS REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10985 OFFSET CUP IMPACTOR CUP IMPACTOR HWA GREATBATCH MEDICAL SA OR71368569 09CYW00002

    Patients

    Seq Age Sex Outcome Treatment
    1