BEUDAMED
    FDA Adverse Event Death Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    MDR report key: 5110695 · Received September 29, 2015

    Report

    Report Number
    0009610622-2015-00450
    Event Type
    Death
    Date Received
    September 29, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540197573
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 12106450S K-WIRE GAMMA 3,2X450MM LOT CODE K128413, CAT 30600105S LAG SCREW, TI GAMMA3 10.5X105MM LOT CODE K962901, CAT 18965040S LOCKING SCREW, FULLY THREADED T2 TIBIA LOT CODE K479719, CAT 13200125S CLOSED TUBE CLIP GAMMA3 LOT CODE K594252. BASED UPON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PATIENT'S IMPLANTED DEVICES CAUSED OR CONTRIBUTED TO PATIENT SUBSEQUENT DEATH 4 DAYS AFTER, HOWEVER THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY TO DOCUMENT THE DEATH FOLLOWING THE IMPLANT SURGERY. DEVICES WILL NOT BE RETURNED AS AUTOPSY WAS NOT PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AS NO ITEM WAS RETURNED NO PHYSICAL EXAMINATION COULD BE CARRIED OUT. THE DHR IDENTIFIED NO DEVIATION IN MANUFACTURING AND THE STERILIZATION CERTIFICATE CONFIRMED THE CORRECT VALUES. THE ITEM WAS MANUFACTURED ACCORDING TO SPECS. INVESTIGATION REVEALED NO NON-CONFORMITY; THEREFORE NO NEW PRODUCT RELATED CAPA WAS INITIATED. GENERAL ASPECTS: THE LISTED IMPLANT IS / WAS INTENDED ONLY TO ASSIST HEALING AND IS / WAS NOT INTENDED TO REPLACE NORMAL BONE STRUCTURES. NO FRACTURE FIXATION DEVICE THAT IS SUBJECT TO MATERIAL FATIGUE CAN BE EXPECTED TO WITHSTAND ACTIVITY LEVELS IN THE SAME WAY AS WOULD A NORMAL HEALTHY BONE. THE FRACTURE FIXATION SYSTEM, THEREFORE, WILL NOT BE AS STRONG, RELIABLE OR DURABLE AS A NORMAL HUMAN BONE. FURTHER, THE ITEM WAS DISTRIBUTED TO THE US IN FEBRUARY 2008 AS SINGLE-USE AND STERILE PRODUCT WITH AN EXPIRY DATE OF JANUARY 31, 2013. THIS MEANS THE ITEM HAS BEEN ON STORAGE FOR MORE THAN 2, 5 YEARS. HOWEVER, FOR THIS CASE THE ITEM MUST HAVE BEEN REPROCESSED. THE EVENT DESCRIPTION RATHER INFORMED THAT ALLEGED SURGERY HAD BEEN COMPLETED SUCCESSFULLY. WITH AVAILABLE INFORMATION A DEFICIENCY OF THE TROCHANTERIC NAIL WAS NEITHER ALLEGED (PATIENT NEVER WALKED ON THE DEVICE) NOR CONFIRMED IN CASE RELEVANT INFORMATION RESP. THE PART(S) BECOME AVAILABLE WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND TO CHANGE THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT WENT INTO VA HOSPITAL FOR A COUMADIN APPOINTMENT AND DUE TO BLEEDING COMPLICATIONS PATIENT WAS TRANSFERRED TO A NON-VA HOSPITAL. THEY TRIED TO RECOVER HIM FROM THAT ISSUE, GIVING HIM BLOOD TRANSFUSION AND FRESH FROZEN PLASMA. PATIENT WAS PUT IN ICU. ON THIRD NIGHT, IN WEE HOURS OF THE MORNING, PATIENT FELL OUT OF BED. RAILS WERE RAISED. PATIENT FELL ON 20TH [MONTH UNKNOWN]. PATIENT BROKE HIS HIP AND HIS SHOULDER. SURGERY OCCURRED ON THE 23RD [MONTH UNKNOWN]. HIP ONLY SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT PASSED AWAY FOUR DAYS AFTERWARDS. NO AUTOPSY PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT WENT INTO (B)(6) HOSPITAL FOR A COUMADIN APPOINTMENT AND DUE TO BLEEDING COMPLICATIONS PATIENT WAS TRANSFERRED TO A NON-(B)(6) HOSPITAL. THEY TRIED TO RECOVER HIM FROM THAT ISSUE, GIVING HIM BLOOD TRANSFUSION AND FRESH FROZEN PLASMA. PATIENT WAS PUT IN ICU. ON THIRD NIGHT, IN WEE HOURS OF THE MORNING, PATIENT FELL OUT OF BED. RAILS WERE RAISED. PATIENT FELL ON (B)(6) [MONTH UNKNOWN]. PATIENT BROKE HIS HIP AND HIS SHOULDER. SURGERY OCCURRED ON THE (B)(6) [MONTH UNKNOWN]. HIP ONLY SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT PASSED AWAY FOUR DAYS AFTERWARDS. NO AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641978 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K552491 04546540197573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other