BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 20370614 · Received October 4, 2024

    Report

    Report Number
    8030965-2024-12487
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 26, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN ASSISTANT
    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, 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. 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 (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH VADHP FOR RIGHT HUMERAL SUPRACONDYLAR FRACTURE. THE PATIENT WAS PLACED IN A SUPINE POSITION, AND THE PROCEDURE WAS DEPLOYED. DURING REDUCTION, THE PROCEDURE PROCEEDED WITHOUT TEMPORARY K-WIRE FIXATION. THE PLATE WAS INSTALLED IN THE ORDER OF INTERNAL SIDE AND POSTERIOR LATERAL SIDE WHILE CHECKING THE FRONT IMAGE WITH AN IMAGE INTENSIFIER. THE SURGEON CONFIRMED THE LENGTH OF THE SCREW AND THE REDUCTION POSITION BY USING AN IMAGE INTENSIFIER AND A SIMPLE POSTOPERATIVE PHOTOGRAPH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 150 MINUTES DELAY. ON (B)(6), A REVISION SURGERY WAS PERFORMED DUE TO ULNAR NERVE PALSY AND SCREW PROTRUSION IN FLEXED POSITION. THE REVISION SURGERY WAS PERFORMED BY A DIFFERENT PHYSICIAN THAN THE PRIMARY SURGERY. ACCORDING TO THE SURGEON AND THE NURSE, THERE WAS NO PROBLEM WITH THE JJ¿S PRODUCT, NUT WITH THE INITIAL SURGICAL TECHNIQUE. IT WAS REDUCTION FAILURE. ALL THE PLATE AND THE SCREW WERE REMOVED, AND REDUCTION WAS PERFORMED AGAIN. SUBSEQUENTLY, THE PLATE WAS INSTALLED IN THE ORDER OF THE POSTERIOR LATERAL SIDE AND INTERNAL SIDE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173249 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention