BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOGGLELOC/WASHERLOC DISP KIT

    MDR report key: 7095173 · Received December 7, 2017

    Report

    Report Number
    0001825034-2017-10775
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 2, 2017
    Report Date
    April 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KDD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE REPORTED PRODUCT WAS RETURNED AND SENT FOR FRACTURE ANALYSIS. FRACTURE ANALYSIS CONCLUDED THAT THE DEVICE SHOWED INDICATIONS OF OVERLOAD FRACTURE BY EXHIBITING DUCTILE DIMPLES. THE SURFACE OF THE FRACTURE HAD SIGNIFICANT DAMAGE THAT WAS SUSPECTED TO BE CAUSED AFTER THE FRACTURE. MATERIAL ANALYSIS OF THE RETURNED DEVICE WAS CONDUCTED AND CONFIRMS THE PRODUCT WAS CONFORMING TO MATERIAL SPECIFICATIONS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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

    CMP-(B)(4). DEVICE PRODUCT CODE - KDD. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE DRILL BIT FRACTURED INSIDE THE PATIENT, CAUSING THE SURGEON TO GO IN AND REMOVE THE FRACTURED PIECE. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874159 TOGGLELOC/WASHERLOC DISP KIT KIT, SURGICAL INSTRUMENT KDD ZIMMER BIOMET, INC. N/A 969580

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R