BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS

    MDR report key: 20426994 · Received October 11, 2024

    Report

    Report Number
    8030965-2024-12730
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    August 15, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. H11 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 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KIM KW, KWAK KY, LEE HJ, KIM SW, SHIM BJ. IS ULNAR SHORTENING OSTEOTOMY EFFECTIVE FOR THE TREATMENT OF ULNAR STYLOID IMPACTION SYNDROME COMPARED TO ULNAR IMPACTION SYNDROME? INT ORTHOP. 2023 NOV;47(11):2787-2794. DOI: 10.1007/S00264-023-05928-1. EPUB 2023 AUG 15. PMID: 37580558. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMED AT EVALUATING THE OUTCOMES OF ULNAR SHORTENING OSTEOTOMY (USO) FOR THE TREATMENT OF ULNAR STYLOID IMPACTION SYNDROME (USIS) AND TO COMPARE THEM WITH THOSE OF USO FOR THE TREATMENT OF ULNAR IMPACTION SYNDROME (UIS). BETWEEN MARCH 2015 AND OCTOBER 2021. A TOTAL OF 144 PATIENTS, WERE DIVIDED INTO A ULNAR IMPACTION SYNDROME(UIS GROUP (GROUP I, N=93) AND A ULNAR STYLOID IMPACTION SYNDROME(USIS GROUP (GROUP II, N=51). AN ULNAR OSTEOTOMY PLATE (DEPUY SYNTHES, WEST CHESTER, PA, USA) WAS USED, AND TWO OR THREE SCREWS WERE DRILLED, TAPPED, AND FTTED WITH 2.7-MM CLINICAL AND RADIOLOGICAL PARAMETERS, INCLUDING DISABILITIES OF THE ARM, SHOULDER, AND HAND (DASH) SCORE, ULNAR VARIANCE, ULNAR STYLOID LENGTH, AND ULNAR STYLOID PROCESS INDEX(USPI), WERE COLLECTED PRE-OPERATIVELY AND ONE YEAR POST-OPERATIVELY, AND A COMPARATIVE ANALYSIS WAS PERFORMED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS (QTY 32): - 24 POST-OPERATIVE ARTHRITIC CHANGE - POST-OPERATIVE RADIOGRAPHIC CARPAL CHONDROMALACIA (RCC) IN STYLOID PROCESS (N=2), ULNAR HEAD (N=1), LUNATE (N=3), AND TRIQUETRUM (N=2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294166 UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention