BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 23574630 · Received November 17, 2025

    Report

    Report Number
    3025141-2025-00698
    Event Type
    Injury
    Date Received
    November 17, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (2 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00697.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, ALTA[?] O, BAYRAM S, AYDIN AS, AYIK Ö, DURMAZ H. MANAGEMENT OF SCAPHOID PSEUDOARTHROSIS SURGERY WITH WIDE-AWAKE LOCAL ANESTHESIA NO TOURNIQUET (WALANT) VERSUS AXILLARY BLOCK ANESTHESIA: COMPARISON OF PATIENT SATISFACTION. PLASTIC SURGERY (OAKVILLE, ONT.). 2024 NOV;32(4):638-645. DOI: 10.1177/22925503231157092. PMID: 39430263; PMCID: PMC11489990. IN THIS PROSPECTIVE STUDY, 23 PATIENTS WITH SCAPHOID PSEUDOARTHROSIS (NONUNION) THAT REQUIRED SURGERY WERE TREATED WITH EITHER WIDE-AWAKE LOCAL ANESTHESIA NO TOURNIQUET (WALANT, N=12) OR AN AXILLARY BLOCK ANESTHESIA (N=11). THIS STUDY WAS CONDUCTED BETWEEN 2015 TO 2021 AND ASSESSED PATIENT SATISFACTION USING A VISUAL ANALOG SCORE (VAS), THE MICHIGAN HAND QUESTIONNAIRE (MHQ), RADIOLOGICAL EXAMINATION FOR BONE UNION, AND A CLINICAL EXAMINATION. ALL PATIENTS WERE TREATED WITH A VOLAR APPROACH AND USED AN ACUMED 2.0MM ACUTRAK SCREW. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO TREATMENT GROUPS. BOTH THE WALANT AND AXILLARY BLOCK ANESTHESIA GROUPS HAD A PATIENT NOT ACHIEVE BONE UNION (2 NONUNION EVENTS TOTAL). FURTHERMORE, THE VAS RESULTS WERE ALSO SIMILAR BETWEEN THE GROUPS ON THE 7TH AND 14TH DAY POSTOPERATIVELY, ALTHOUGH THE VAS SCORE WAS SIGNIFICANTLY LOWER IN THE FIRST THREE (3) DAYS POST-SURGERY IN THE WALANT GROUP. NO SIGNIFICANT DIFFERENCES WERE SEEN IN THE 12 MONTH MHQ SCORES, TIME TO UNION, OR OPERATION TIME. THUS, THE AUTHORS CONCLUDED THAT THE WALANT TECHNIQUE IS SAFE AND EFFECTIVE TO TREAT SCAPHOID PSEUDOARTHROSIS (NONUNION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280746 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other