BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN

    MDR report key: 14254598 · Received April 29, 2022

    Report

    Report Number
    8030965-2022-02833
    Event Type
    Injury
    Date Received
    April 29, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    10886982085931
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. PART # 04.118.550S, LOT # 1L58263, MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 03 SEP2021. EXPIRATION DATE: 01 SEP2031. SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 04.118.550. NON-STERILE LOT # 273P249. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 19 JUL 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION WITH THE TROCHANTERIC FIXATION NAIL- ADVANCED FOR THE FRACTURE OF THE DIAPHYSEAL FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SECONDARY FRACTURE HAD OCCURRED. A TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE, TFNA FEMORAL NAIL Ø11 125° L200 TIMO15, LOCKSCREW Ø5 L34 F/NAILS TAN- LIGHT GREEN, AND A TFNA END CAP EXTENSION 0 TAN WERE USED DURING THE PROCEDURE. ON (B)(6), 2022, THE REVISION SURGERY WAS PERFORMED TO REMOVE THE TROCHANTERIC FIXATION NAIL- ADVANCED AND FIX THE FRACTURE WITH A LONG GAMMA NAIL AND SCREWS. ACCORDING TO THE SURGEON, THIS EVENT WAS CAUSED BY A TECHNICAL ERROR DUE TO POOR IMPLANT INSERTION POINT, NOT PRODUCT MALFUNCTION. THE SURGEON THOUGHT THAT THE PATIENT HAD NOT FALLEN. THE SURGEON GUESSED THAT THE SECONDARY FRACTURE MAY BE A STRESS FRACTURE BECAUSE THE INSERTION POINT WAS POSTERIOR, AND THE TIP OF NAIL WAS HITTING THE ANTERIOR CORTICAL BONE. NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077853 LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN SCREW, FIXATION, BONE HWC SYNTHES GMBH 04.005.524S 8L55133 10886982085931

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention TFNA END CAP EXTENS. 0 TAN| TFNA FEM NAIL Ø11 125° L200 TIMO15| TFNA FENESTRATED HELICAL BLADE 90 - SILE