BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW

    MDR report key: 13440250 · Received February 3, 2022

    Report

    Report Number
    0009613350-2022-00056
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    January 12, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024298439
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: CMN FEMORAL NAIL, CCD 125°, RIGHT,11.5 MM, 38 CM CATALOG#: 47-2493-380-11 ; LOT#: 2973776. THE MANUFACTURER DID NOT RECEIVE THE DEVICE 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00054.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS SUBMITTED REPORT. INVESTIGATION RESULTS ARE NOW AVAILABLE. DURING THE INVESTIGATION IT WAS CONCLUDED THAT THE DEVICE PREVIOUSLY SUBMITTED ON THIS MEDWATCH IS A CONCOMITANT AND NOT A MAIN DEVICE OF THIS EVENT. PLEASE REMOVE FROM YOUR RECORDS. THIS DEVICE IS REPORTED IN 0009613350-2022-00054-1 AS A CONCOMITANT DEVICE. ZIMMER'S REFERENCE: (B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: NAIL SNAPPED AT LAG SCREW JUNCTION.

    Description of Event or Problem · 0

    INVESTIGATION OF THIS INCIDENT HAS BEEN COMPLETED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED FURTHER ANALYSIS OF THE EVENT HAS DETERMINED THAT ACCORDING TO COMPLAINT DESCRIPTION, THE DEVICE HERE REPORTED IS NOT A MAIN BUT AN ASSOCIATES DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748485 ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3071946 00889024298439

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SEE H10 NARRATIVE