BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR REAMER HANDLE

    MDR report key: 3970992 · Received July 8, 2014

    Report

    Report Number
    9614497-2014-00184
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    February 19, 2013
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY GREATBATCH AND INVESTIGATION IS IN PROCESS. ONCE INVESTIGATION IS COMPLETED, A FOLLOW UP MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED TO GREATBATCH MEDICAL FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE TRI-FLAT COUPLER END THAT BROKE WAS NOT RETURNED FOR EVALUATION. ON THE RETURNED INSTRUMENT, THERE IS EVIDENCE OF DRIVER IMPACT AND IT HAS BEEN DAMAGED. THIS INSTRUMENT HAS BEEN MISUSED AS THERE IS A DEPRESSION OR DENT OBSERVED ON THE RETURNED INSTRUMENT THAT MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE. NOTHING IN THE MANUFACTURING PROCESS COULD EXPLAIN THIS DEFECT. THE ISSUE COULD NOT OCCUR DURING NORMAL USE OF THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING AN UNKNOWN PATIENT PROCEDURE, THE REAMER HANDLE BROKE OFF CAUSING IT TO HIT THE PHYSICIAN IN THE FACE RESULTING IN BLEEDING. CUSTOMER STATES THE MALFUNCTION DID NOT CAUSE INJURY TO THE PATIENT UNDERGOING THE PROCEDURE. PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398022 ACETABULAR REAMER HANDLE REAMER HANDLE LXH GREATBATCH MEDICAL SA 2102-0410 V38396001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other