BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL

    MDR report key: 17479975 · Received August 8, 2023

    Report

    Report Number
    8030965-2023-09978
    Event Type
    Injury
    Date Received
    August 8, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    10886982274618
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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 HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE#:04.168.495S-US LOT #:1249P66 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCE'S / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 18/08/2022 MANUFACTURING SITE: (B)(6) EXPIRY DATE :31/07/2032 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FNS (FEMORAL NECK SCREW) CUTOUT. DURING A REMOVAL PROCEDURE, THE FNS LOCKING SCREW WAS COLD WELDED INTO THE PLATE. THE PATIENT HAD AN ADDITIONAL FRACTURE DURING REMOVAL OF THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT TOOK LONGER THAN EXPECTED ACCORDING TO THE SURGEON. THE PATIENT OUTCOME WAS SATISFACTORY. THIS REPORT INVOLVES ONE ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796769 ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 1249P66 10886982274618

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE| 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE| BOLT FOR FEMORAL NECK SYS 90 LENGTH-SILE| FEMORAL NECK SYSTEM PL 2 HOLE - STERILE