BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEPHALOMEDULLARY LAG SCREW REAMER 3.2 MM

    MDR report key: 8864189 · Received August 6, 2019

    Report

    Report Number
    0001822565-2019-03311
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 11, 2019
    Report Date
    December 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K091566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CEPHALIC SCREW AUGER FRACTURED AT THE OPERATIVE SITE DURING THE BONE'S DRILLING. VERIFICATION OF THE AXES OF THE GUIDES HAD BEEN DONE AND ALL WAS IN CONFORMITY. THERE WAS A SURGICAL DELAY OF ONE HOUR TO REMOVE THE FRACTURED PIECES. NO ADDITIONAL PATIENT CONSEQUENCES ARE KNOWN AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN: (B)(6). THE DEVICE LOCATION IS UNKNOWN AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEPHALIC SCREW AUGER FRACTURED AT THE OPERATIVE SITE DURING THE BONE'S DRILLING. VERIFICATION OF THE AXES OF THE GUIDES HAD BEEN DONE AND ALL WAS IN CONFORMITY. THERE WAS A SURGICAL DELAY OF ONE HOUR. NO ADDITIONAL PATIENT CONSEQUENCES ARE KNOWN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659019 CEPHALOMEDULLARY LAG SCREW REAMER 3.2 MM ROD, FIXATION HSB ZIMMER BIOMET, INC. 64035389

    Patients

    Seq Age Sex Outcome Treatment
    1 Other