BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN, CMN LAG SCREW REAMER, SHORT

    MDR report key: 13018628 · Received December 16, 2021

    Report

    Report Number
    0009613350-2021-00671
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    November 27, 2021
    Report Date
    April 20, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024276260
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION RELATED TO THE EVENT. MEDICAL RECORDS WERE NOT PROVIDED. FOREIGN MATERIAL IN PATIENTS BODY: IN ACCORDANCE WITH ISO 10993-1THE ZNN CM SMALL GUIDE AND SHORT INSTRUMENTS ARE CATEGORIZED AS EXTERNAL COMMUNICATING DEVICES WITH TISSUE/BONE CONTACT FOR LESS THAN 24 HOURS. THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE. PIECES OF THE REAMER ARE STILL IN THE FEMUR HEAD AND CANT BE REMOVED BUT IN THE END ZNN CEPHALOMEDULLARY IS IN THE PATIENT WITH NO COMPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY ZNN CEPHALOMEDULLARY LAG SCREW REAMER - SHORT BREAK WHEN WAS REAMING IN THE PATIENT. PATIENT INVOLVEMENT. DELAY IN PROCEDURE: 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917730 ZNN, CMN LAG SCREW REAMER, SHORT ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 4502612584 00889024276260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H