BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSANAIL TIBIAL NAIL

    MDR report key: 6605275 · Received June 1, 2017

    Report

    Report Number
    0001825034-2017-03502
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    May 3, 2015
    Report Date
    June 9, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03530, 0001825034-2017-03531, 0001825034-2017-03532, 0001825034-2017-03533 MEDICAL PRODUCTS- BONE SCREW CATALOG#:1402244 LOT#: UNK, BONE SCREW CATALOG#:1402236 LOT#: UNK, SCREW CATALOG#:151550 LOT#:UNK, SCREW CATALOG#:151560 LOT#:UNK, THREADED GUIDE PIN CATALOG#:903003004 LOT#:UNK, DRILL BIT CATALOG#:281012138 LOT#:UNK, DRILL BIT CATALOG#:281012144 LOT#: UNK, BALL NOSE GUIDE WIRE CATALOG#:281001080 LOT#:862670, BALL NOSE GUIDE WIRE CATALOG#:281001100 LOT#:661670.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE FOR THIS COMPLAINT, AS THE NAIL WAS NOT REMOVED IN THIS PROCEDURE. THIS COMPONENT IS BEING REPORTED FOR A DIFFERENT EVENT. PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-03764. 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 IS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A TIBIAL FRACTURE FIXATION TRAUMA NAIL PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND A RASH BEGINNING A FEW MONTHS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386891 VERSANAIL TIBIAL NAIL PLATE, FIXATION HRS BIOMET TRAUMA N/A DNLCTG

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other