BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORT SCREW 5.5X60MM NS

    MDR report key: 6605289 · Received June 1, 2017

    Report

    Report Number
    0001825034-2017-03533
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    May 19, 2016
    Report Date
    March 8, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK972183
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    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). 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: 0001825034-2017-03502, 0001825034-2017-03530, 0001825034-2017-03531, 0001825034-2017-03532. MEDICAL PRODUCTS-TIBIAL NAIL CATALOG#:181209315 LOT#:DNLCTG, BONE SCREW CATALOG#:1402244 LOT#: UNK, BONE SCREW CATALOG#:1402236 LOT#: UNK, SCREW CATALOG#:151550 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. 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'S SCREWS WERE REMOVED APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO EXPERIENCING PAIN LEADING TO AMBULATION DIFFICULTIES AND A RASH BEGINNING A FEW MONTHS POST-IMPLANTATION. OPERATIVE NOTES RECEIVED REPORT THE PATIENT HAD COMPLAINTS OF PAIN RELATED TO PROMINENT PROXIMAL AND DISTAL LOCKING SCREWS. THE SCREWS WERE REMOVED AND NOTED TO BE INTACT. X-RAY REVIEW SHOWS THAT SCREWS BACKED OUT.

    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A TIBIAL FRACTURE FIXATION TRAUMA NAIL PROCEDURE. SUBSEQUENTLY, THE PATIENT'S SCREWS WERE REMOVED APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO EXPERIENCING PAIN LEADING TO AMBULATION DIFFICULTIES AND A RASH BEGINNING A FEW MONTHS POST-IMPLANTATION. OPERATIVE NOTES RECEIVED REPORT THE PATIENT HAD COMPLAINTS OF PAIN RELATED TO PROMINENT PROXIMAL AND DISTAL LOCKING SCREWS. THE SCREWS WERE REMOVED AND NOTED TO BE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387006 CORT SCREW 5.5X60MM NS ROD, FIXATION HSB BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O| R