BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 3908235 · Received June 5, 2014

    Report

    Report Number
    9614497-2014-00058
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 31, 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

    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, STATED THERE WAS NO FAILURE FOUND WITH THE RETURNED IMPACTOR AND THE REPORTED RESULTS COULD NOT BE DUPLICATED. NO FURTHER INVESTIGATION IS REQUIRED. COMPLAINT SAMPLE NOT RETURNED TO THE MANFACTURER (GREATBATCH).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROCESS. ONCE COMPLETED A FOLLOW-UP MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS ON(B)(6) 2014; DURING AN UNK PROCEDURE AFTER PHYSICIAN IMPACTED THE SHELL THEY ATTEMPTED TO REMOVE THE IMPACTOR FROM THE SHELL AND COULD NOT TURN RELEASE KNOB AFTER A PERIOD OF TIME. CUSTOMER STATES THERE WAS A DELAY IN SURGERY OF GREATER THAN 30 MINUTES. NO ADDITIONAL INFO WAS PROVIDED ON PT OUTCOME. PT AGE AND GENDER ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329835 OFFSET CUP IMPACTOR OFFSET CUP IMPACTOR HWA GREATBATCH MEDICAL SA OR71368569 11BM09251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention