BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE

    MDR report key: 21784808 · Received April 7, 2025

    Report

    Report Number
    8030965-2025-03238
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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. 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 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: CHEN H, LIANG J, HE C, GU X, XU C, DENG A, WANG GH. ULTRASONOGRAPHY-ASSISTED ASSESSMENT OF THE INFLUENCE OF THE VOLAR PROMINENCE OF THE PLATE ON THE MEDIAN NERVE IN DISTAL RADIUS FRACTURES. INJURY. 2023 AUG;54(8):110835. DOI: 10.1016/J.INJURY.2023.05.066. EPUB 2023 JUN 1. PMID: 37321881. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY TO EXPLORE THE EFFECT OF DIFFERING VOLAR LOCKING PLATE (VLP) PROMINENCE ON THE MEDIAN NERVE (MN) IN DISTAL RADIUS FRACTURE (DRF) WITH ULTRASOUND ASSISTANCE TO GUIDE CLINICAL TREATMENT. BETWEEN JANUARY 2019 AND MAY 2021, A TOTAL OF 44 PATIENTS (18 MALES AND 26 FEMALES; WITH A MEAN AGE OF 56.8 YEARS) WITH VLP INTERNAL FIXATION FOR DRF. VA-LCP TWO-COLUMN DISTAL RADIUS PLATES 2.4 (SYNTHES® GMBH, OBERDORF, SWITZERLAND) PLATES WERE USED IN THIS STUDY WITH THE PALMAR HENRY OR FLEXOR CARPI RADIALIS APPROACH. FOLLOW-UP TIME WAS APPROXIMATELY 13 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES VA-LCP TWO-COLUMN DISTAL RADIUS PLATES 2.4. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 2.4 MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATES/SCREWS (QTY 1). 1 PATIENT EXPERIENCED EXTENSOR TENDON RUPTURE. THE PLATE WAS REMOVED 3 MONTHS POSTOPERATIVELY IN COMBINATION WITH TENDON REPAIR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: 2.4 VALCP VOL RIM DIST RAD (QTY 13). 13 PATIENTS EXCESSIVE PLATE PROTRUSION (SOONG GRADE 2) INCREASED THE CROSS-SECTIONAL AREA OF THE MEDIAN NERVE (MN). RECOMMEND PLACING THE PLATE AS PROXIMAL AS POSSIBLE DURING VLP TREATMENT OF DRFS TO AVOID EXCESSIVE BULGES AFFECTING THE MN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614427 UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown