BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOGGLELOC/WASHERLOC DISPOSABLE KIT

    MDR report key: 6691018 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04225
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 8, 2017
    Report Date
    January 6, 2018
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    KDD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS EVALUATED, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A COMPLAINT HISTORY SEARCH WAS PERFORMED AND NO ACTIONS ARE REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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.

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: - (B)(6). DEVICE PRODUCT CODE - KDD. UDI NUMBER - (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT HAS BEEN REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, METAL SHAVINGS WERE NOTICED IN THE KNEE JOINT AFTER USING THE 2.4MM DRILL TIP PIN FROM THE KIT. IT IS UNKNOWN IF ALL METAL SHAVINGS WERE SUCCESSFULLY REMOVED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, METAL SHAVINGS WERE NOTICED IN THE KNEE JOINT AFTER USING THE 2.4MM DRILL TIP PIN FROM THE KIT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471748 TOGGLELOC/WASHERLOC DISPOSABLE KIT KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD BIOMET SPORTS MEDICINE N/A 318780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other