BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RATTLER XL CANNULATED INTERFERENCE SCREW

    MDR report key: 7177240 · Received January 9, 2018

    Report

    Report Number
    0001825034-2017-11214
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    October 5, 2017
    Report Date
    January 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK041274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#948064 5X20MM RATTLER XL CANN SCREW LOT# 243760, ITEM#948078 6X15MM RATTLER XL CANN SCREW LOT# 564040. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2017-11212, 0001825034 -2017-11213.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FLEXOR HALLUCIS LONGUS TENDON TRANSFER PROCEDURE, A SCREW FRACTURED DURING ATTEMPTED IMPLANTATION. A LARGER SCREW HOLE WAS DRILLED AND A SECOND, LARGER SCREW WAS ATTEMPTED, WITH THE SAME RESULTS. A THIRD SCREW ALSO FRACTURED, BUT WAS FIXED WELL ENOUGH TO REMAIN IMPLANTED AND WAS RETAINED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18466 RATTLER XL CANNULATED INTERFERENCE SCREW SCREW, FIXATION, BONE HWC ZIMMER BIOMET, INC. N/A 280900

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R