BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-DBLE LEAD CORT SCR

    MDR report key: 7812509 · Received August 24, 2018

    Report

    Report Number
    0001825034-2018-08512
    Event Type
    Injury
    Date Received
    August 24, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K063570
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRACTURED SCREW WAS ON OF THE FOLLOWING PART/LOT COMBINATIONS. IT IS UNCERTAIN AT THIS TIME WHICH WAS THE FRACTURED SCREW: PN 14-405036 LN 468230: MANUFACTURE DATE: 12/17/2016, EXPIRATION DATE: 12/17/2026, K063570, HSB, PN 14-405034 LN 671520: MANUFACTURE DATE: 4/8/2016, EXPIRATION DATE: 4/8/2026, K063570, HSB, PN 14-405042 LN 325250: MANUFACTURE DATE: 3/15/2016, EXPIRATION DATE: 3/15/2026, K063570, HSB, PN 14-405038 LN 393060: MANUFACTURE DATE: 3/17/2016, EXPIRATION DATE: 3/17/2026, K063570, HSB. OTHER ASSOCIATED PRODUCTS: TIBIAL NAIL 7.5MM X 360MM CATALOG#: 40036 LOT#: 706290, TIBIAL NAIL 9.0MM X 360MM CATALOG#: 40336 LOT#: 312370.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #'S FOR POSSIBLE DEVICES - (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED. DEVICE HISTORY RECORDS FOR ALL POSSIBLE SCREWS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE IS RELATED TO PATIENT TRAUMA. PATIENT DROPPED A HEAVY ITEM ON THEIR FOOT, FRACTURING ONE OF THE SCREWS. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: UNKNOWN TIBIAL NAIL CATALOG#: NI LOT#: NI, UNKNOWN CORTICAL SCREWS CATALOG#: NI, LOT#: NI. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TIBIAL NAIL TRAUMA PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SCREW REMOVAL DUE TO FRACTURE OF A SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653460 TI-DBLE LEAD CORT SCR ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R