BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 3908237 · Received June 5, 2014

    Report

    Report Number
    9614497-2014-00059
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    June 22, 2011
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROCESS. ONCE COMPLETED A F/U MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED TO GREATBATCH FOR EVALUATION AND THE REPORTED EVENT CANNOT BE CONFIRMED. A PROCESS REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. THE INITIAL INVESTIGATION COMPLETED BY THE DISTRIBUTOR, ATTRIBUTED THE CAUSE OF THE MALFUNCTION TO BE FATIGUE LOADING OF THE WELD JOINT AND BREAKAGE CAUSED BY REPEATED IMPACTS. NO FURTHER INVESTIGATION IS REQUIRED. COMPLAINT SAMPLE NOT RETURNED TO THE MANUFACTURER (GREATBATCH).

    Additional Manufacturer Narrative · 1

    (B)(4) MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS ON (B)(6) 2014; DURING AN UNKNOWN PROCEDURE PHYSICIAN IMPACTED THE R3 SHELL AND WHEN THEY WENT TO REMOVE THE IMPACTOR IT WOULD NOT UNTHREADED FROM THE SHELL. MANY ATTEMPTS WERE MADE TO FREE THE IMPACTOR, BUT ALL FAILED. CUSTOMER STATES THERE WAS A DELAY IN SURGERY OF GREATER THAN 30 MINUTES. NO ADD'L INFO WAS PROVIDED ON PATIENT OUTCOME. PATIENT AGE AND GENDER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329743 OFFSET CUP IMPACTOR OFFSET CUP IMPACTOR HWA GREATBATCH MEDICAL SA OR71368569 11MB09251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention