BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9 TI CANNULATED HUMERAL NAIL-EX/260-SILE

    MDR report key: 16075001 · Received December 29, 2022

    Report

    Report Number
    8030965-2022-11676
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    PMA / PMN Number
    K033071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY: 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 H3, H4, H6: DEVICE HISTORY LOT PART # 04.001.432S SYNTHES LOT # H092627 SUPPLIER LOT # N/A RELEASE TO WAREHOUSE DATE:02 MAY 2016 MANUFACTURED BY: SYNTHES MONUMENT NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 THE NAIL WAS SUCCESSFULLY REMOVED, BUT NOT WITHOUT COMPLICATIONS. WHEN REMOVING THE DISTAL INTERLOCKING SCREW, THE HEAD OF THE SCREW SNAPPED OFF. MANY ATTEMPTS WERE MADE TO OVER REAM AND EXTRACT THE SCREW WITH SCREW REMOVAL COMPONENTS, BUT WERE UNSUCCESSFUL. ULTIMATELY, AND INCISION WAS MADE ON THE POSTERIOR SIDE OF THE HUMERUS, AND THE SCREW WAS LOCATED AND TAMPED THROUGH THE HOLE FROM THE OPPOSITE SIDE. THE NAIL EXTRACTION PROCEEDED, HOWEVER A FRACTURE OCCURRED AT THE DISTAL INTERLOCKING SCREW LOCATIONS LIKELY BECAUSE OF BONY OVERGROWTH INSIDE OF THE SCREW HOLES BASED ON MY OBSERVATION. THE FRACTURE WAS REPAIRED WITH PLATES AND SCREWS AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE NAIL WAS REMOVED BECAUSE IT WAS PROMINENT IN THE HUMERAL HEAD. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) 9 TI CANNULATED HUMERAL NAIL-EX/260-SILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2612401 9 TI CANNULATED HUMERAL NAIL-EX/260-SILE NAIL, FIXATION, BONE JDS SYNTHES GMBH 04.001.432S H092627

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention UNK - END CAPS: HUMERAL NAIL| UNK - PLATES: TRAUMA| UNK - SCREWS: TRAUMA