BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 5354395 · Received January 8, 2016

    Report

    Report Number
    3004976965-2015-00030
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    March 31, 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

    ADDITIONAL INFORMATION FROM CUSTOMER WAS RECEIVED WHICH IDENTIFIED THE DEVICE MANUFACTURING SITE. (B)(4). GREATBATCH WAS ABLE TO CROSS-REFERENCE THE PURCHASE ORDER NUMBER WITH THE CORRESPONDING GREATBATCH LOT NUMBER. A MANUFACTURING REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND.(B)(4)

    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 INITIAL INVESTIGATION WAS COMPLETED BY THE CUSTOMER (SMITH & NEPHEW), AND THEY ATTRIBUTED THE CAUSE OF THE MALFUNCTION TO BE FATIGUE LOADING OF THE WELD JOINT CAUSED BY REPEATED IMPACTS. NO FURTHER INVESTIGATION REQUIRED. COMPLAINT INFORMATION WAS PROVIDED BY SMITH AND NEPHEW. 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 WELD CAME LOOSE AND THE IMPACTOR WAS UNABLE TO HOLD THE CUP SECURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12544 OFFSET CUP IMPACTOR CUP IMPACTOR HWA GREATBATCH MEDICAL SA OR71368569 12CM16223

    Patients

    Seq Age Sex Outcome Treatment
    1