BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 20915320 · Received December 12, 2024

    Report

    Report Number
    8030965-2024-14933
    Event Type
    Injury
    Date Received
    December 12, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: XU X, LV Y, CUI Z, FAN J, ZHOU F, TIAN Y, JI H, ZHANG Z, GUO Y, YANG Z, HOU G. NON-SLIDING FIXATION SHOWS IMPROVED CLINICAL OUTCOMES FOR DISPLACED FEMORAL NECK FRACTURES AS COMPARED TO SLIDING FIXATION. FRONT SURG. 2022 MAR 24;9:826159. DOI: 10.3389/FSURG.2022.826159. PMID: 35402501; PMCID: PMC8987303. THE OBJECTIVE OF THE STUDY IS TO COMPARE THE CLINICAL OUTCOMES BETWEEN USE OF SLIDING FIXATION (3 CANNULATED SCREWS, TCS) AND NON-SLIDING FIXATION (4 CANNULATED SCREWS, FCS) IN THE TREATMENT OF FEMORAL NECK FRACTURES. BETWEEN JANUARY, 2018 AND DECEMBER, 2019, 102 PATIENTS WITH FRESH FEMORAL NECK FRACTURES TREATED WITH TCS (60 CASES) AND FCS (42 CASES) WERE INCLUDED IN THE STUDY. THERE WERE 36 MALES AND 66 FEMALES WITH A MEAN AGE OF 60.9 (RANGE, 18¿86) AND A MEAN BMI OF 22.7 ± 3.4 KG/M2. AFTER A SUCCESSFUL CLOSED REDUCTION, THE ROUTINE SURGICAL PROCEDURE WAS FOLLOWED TO IMPLANT TCS AND FCS (ALL IMPLANTS WERE PROVIDED BY DEPUY SYNTHES PRODUCTS, INC.). FOR ALL PATIENTS, THE FIRST 3 CANNULATED SCREWS WERE IMPLANTED IN A STANDARD INVERTED TRIANGLE PATTERN, AND THE 4TH CANNULATED SCREW WAS IMPLANTED AT AN ANGLE NOT PARALLEL TO THE OTHER 3 CANNULATED SCREWS. FOLLOW-UPS WERE PERFORMED AT 1, 3, 6, 12, AND 24 MONTHS AFTER SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SYNTHES CANNULATED SCREWS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN DEPUY SYNTHES CANNULATED SCREWS (QTY 33) -1 PATIENT HAD AN INTERNAL FIXATION CUT OUT. TREATMENT WAS NOT REPORTED. -4 PATIENTS HAD FRACTURE NON-UNION. TREATMENT WAS NOT REPORTED. -3 PATIENTS HAD FEMORAL NECK SHORTENING OF MORE THAN 10 MM WITH VARIOUS DEGREES OF CLAUDICATION. TREATMENT WAS NOT REPORTED. -25 PATIENTS HAD SOFT TISSUE IRRITATION OF THE THIGH. TREATMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152367 UNK - SCREWS: CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention