BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESS SENTINEL FLEX IM REAMER 9.5 MM

    MDR report key: 6388221 · Received March 8, 2017

    Report

    Report Number
    0001822565-2017-01544
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    November 21, 2016
    Report Date
    April 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT HAS BEEN DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1822565-2017-01543 AND 001544).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION, THUS THE REPORTED EVENT WAS NOT CONFIRMED. NO PRODUCT WAS RETURNED FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE DEVICES HAD POTENTIAL FIELD HISTORIES OF APPROXIMATELY 10.5 AND 12.5 YEARS RESPECTIVELY. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRAMEDULLARY FEMORAL FIXATION PROCEDURE, THE REAMER CAME APART WHILE REAMING. THE PIECES WERE ALL REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER REAMER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171384 PRESS SENTINEL FLEX IM REAMER 9.5 MM INSTRUMENT, REAMER HWE ZIMMER, INC. N/A 60252566

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention