BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE SENTINEL FLEXIBLE REAMER

    MDR report key: 2597102 · Received May 31, 2012

    Report

    Report Number
    1822565-2012-01183
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Report Date
    January 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR CLOSER EVALUATION AND TO DETERMINE A CLEAR ROOT CAUSE. REAMERS ARE SUBJECT TO BREAKING DURING SURGERY IF USER APPLIES ECCENTRIC LOADING TO THESE FLEXIBLE REAMERS, CAUSING BENDING MOMENT LOADS. ALTHOUGH IT WAS REPORTED THAT THE REAMER WAS USED IN A NORMAL FASHION DURING SURGERY WHEN IT BROKE AT THE HEAD/SHAFT JUNCTION, THERE IS NO INFO AVAILABLE REGARDING HOW THE REAMER WAS DURING PRIOR SURGERIES. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE STANDARD REAMING PROCEDURE THE HEAD OF THE REAMER DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE SENTINEL FLEXIBLE REAMER HWE ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1