BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: 3.5 MM CORTEX

    MDR report key: 20744490 · Received November 21, 2024

    Report

    Report Number
    8030965-2024-14215
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE. 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. 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: TAKAHASHI H, TAKEGAMI Y, TOKUTAKE K, KATAYAMA Y, IMAGAMA S. <EDITORS' CHOICE> HOOK PLATE FIXATION VERSUS LOCKING PLATE FIXATION FOR DISTAL CLAVICLE FRACTURE: A MULTICENTER PROPENSITY SCORE-MATCHED STUDY. NAGOYA J MED SCI. 2023 MAY;85(2):223-232. DOI: 10.18999/NAGJMS.85.2.223. PMID: 37346837; PMCID: PMC10281843. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO CLARIFY THE FOLLOWING: DOES THE LOCKING PLATE OFFER BETTER CLINICAL OUTCOMES THAN THE HOOK PLATE? IS BONE UNION BETTER WITH A LOCKING PLATE THAN HOOK PLATE? AND ARE COMPLICATIONS DIFFERENT BETWEEN THE LOCKING PLATE AND HOOK PLATE. BETWEEN JANUARY 2014 AND DECEMBER 2018, A TOTAL 178 PATIENTS (159 MALE AND 19 FEMALE) WERE INCLUDED IN THE STUDY. AFTER PROPENSITY SCORE MATCHING, THESE PATIENTS WERE DIVIDED INTO TWO GROUPS. LOCKING PLATE GROUP (GROUP L) CONSIST OF 49 PATIENTS (44 MALE AND 5 FEMALE) WITH A MEAN AGE OF 43.4 AND 12.7 TREATED WITH LCP (DEPUY SYNTHES) OR VARIAX (STRYKER) PLATE WHILE THE HOOK PLATE GROUP (GROUP H) CONSIST OF 49 PATIENTS (43 MALE AND 6 FEMALE) WITH A MEAN AGE OF 45.9 AND 15.1 TREATED WITH LCP (DEPUY SYNTHES) PLATE. THE MEAN FOLLOW-UP PERIOD FOR (GROUP L) WAS 12.9 AND 6¿22 WHILE THE (GROUP H) WAS 9.0 AND 6¿23. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES LCP ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP HOOK PLATE/ SCREWS (15 QTY). 3 PATIENTS IN HOOK PLATE GROUP CONNOT BE CONFIRM BONE UNION. 4 PATIENTS IN HOOK PLATE GROUP HAD IMPINGEMENT. 3 PATIENTS IN HOOK PLATE GROUP HAD INFECTION. 1 PATIENT IN HOOK PLATE GROUP HAD SCAR PROBLEM. 3 PATIENTS IN HOOK PLATE GROUP HAD REDUCTION LOSS. 1 PATIENT IN HOOK PLATE GROUP HAD RE-OPERATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED UNK - PLATES: HOOK PLATE (9 QTY). 9 PATIENTS IN HOOK PLATE GROUP HAD PLATE MIGRATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED UNK - SCREWS: 3.5 MM CORTEX (2 QTY). 2 PATIENTS IN HOOK PLATE GROUP HAD SCREW BACKOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447570 UNK - SCREWS: 3.5 MM CORTEX SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown