BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER

    MDR report key: 12484840 · Received September 16, 2021

    Report

    Report Number
    8030965-2021-07818
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 19, 2021
    Product Code
    HWC
    UDI-DI
    7611819789845
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: PART: 04.005.534S; LOT: L874482; MANUFACTURING SITE: SELZACH; SUPPLIER: (B)(4); RELEASE TO WAREHOUSE DATE: APRIL 27, 2018; EXPIRATION DATE: APRIL 1, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE: PART: 04.005.534; LOT: L862200. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE TROCHANTERIC FEMUR FRACTURE WITH THE NAIL IN QUESTION. THE SURGEON INSERTED THE TFNA LONG NAIL WITH ATYPICAL FEMORAL DIAPHYSEAL FRACTURES. THE MEDULLARY CAVITY OF THE PATIENT WAS SMALL, SO THE SURGEON INSERTED THE REAMING ROD AND WAS REAMING UNTIL F11.5MM AND INSERTED THE NAIL(F10MM). THE SURGEON FINISHED REDUCTION, BOTH NAIL LENGTH AND BLADE DEPTH WERE GOOD. THE SURGEON USED TWO THE LOCKING SCREW FOR 1 STATIC LOCKING AND 1 DYNAMIC LOCKING. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT RETURNED TO HER DAILY LIFE WITHOUT ANY PAIN. HER WALKING ABILITY GRADUALLY DECLINED AND SHE FELT SEVERE PAIN A WEEK AGO. THE X-RAY SHOWED THAT THE NAIL WAS BROKEN, AND THERE WAS A PROBLEM WITH THE LATERAL CORTICAL BONE. THE SURGEON WILL PERFORM THE REVISION SURGERY ON (B)(6) 2021, AND REMOVE THE BROKEN NAILS AND THE TFNA LONG NAIL IMPLANT AGAIN. THE NAIL BROKE 3 MONTHS AFTER THE SURGERY, AND IS TOO EARLY. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382543 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER SCREW, FIXATION, BONE HWC L874482 7611819789845

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LOCKSCR Ø5 L36 F/NAILS TAN.| TFNA END CAP EXTENS. 0 TAN.| TFNA FEM NAIL Ø10 R 125° L340 TIMO15.| TFNA HELICAL BLADE PERF L85 TAN.