BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUTRAK SCREW

    MDR report key: 22198469 · Received June 12, 2025

    Report

    Report Number
    3025141-2025-00156
    Event Type
    Injury
    Date Received
    June 12, 2025
    Report Date
    June 12, 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 OF THE REPORTED EVENT IS UNKNOWN. RELATED REPORT NUMBERS: 3025141-2025-00177.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IN THE FOLLOWING ARITCLE CITED, "SUGIURA H, TATEBE M, YONEDA H, ET AL. A SMALL RATIO OF PROXIMAL TO DISTAL BONE FRAGMENTS IS A RISK FACTOR FOR SCAPHOID NONUNION: A VOLUMETRIC ANALYSIS OF PREOPERATIVE CT. JOURNAL OF WRIST SURGERY. 2025 JUN;14(3):226-232. DOI: 10.1055/S-0044-1779286. PMID: 40395824; PMCID: PMC12088806." A RETROSPECTIVE STUDY WAS CONDUCTED AT THREE HOSPITALS IN JAPAN BETWEEN 2008 AND 2020 THAT INCLUDED 78 PATIENTS TREATED FOR A SCAPHOID FRACTURE WITH AN ILIAC CREST OR DISTAL RADIUS BONE GRAFT. THE STUDY AIM WAS TO DETERMINE RISK FACTORS FOR POSTOPERATIVE NONUNION EVENTS. NONUNION WAS DEFINED AS NO EVIDENCE OF UNION ON PLAIN RADIOGRAPHY OR CT IMAGES MORE THAN 3 MONTHS AFTER INJURY. FOR THE 78 PATIENTS TREATED FOR A SCAPHOID FRACTURE, 17 PATIENTS WERE TREATED WITH AN ACUMED ACUTRAK SCREW, 59 PATIENTS WERE TREATED WITH A MEIRA DTJ SCREW, AND THE REMAINING 2 PATIENTS HAD AN UNKNOWN FIXATION METHOD. OF THE 78 PATIENTS (74 MALES AND 4 FEMALES), 65 ACHIEVED UNION AND 13 HAD PERSISTENT NONUNION. THE OVERALL UNION RATE WAS 83.3%. FOUR OF THE 13 PERSISTENT NONUNION PATIENTS UNDERWENT A REOPERATION. THE MEAN FOLLOW-UP PERIOD WAS 15.2 MONTHS IN BOTH THE UNION (RANGE 3-59 MONTHS) AND PERSISTENT NONUNION (RANGE 6-33 MONTHS) GROUPS. OF THE 13 NONUNION PATIENTS, THE FIXATION MATERIAL REPORTED WERE 2 ACUTRAK SCREWS, 10 DTJ SCREW FIXATION MATERIAL (MEIRA, NAGOYA, JAPAN) AND 1 UNKNOWN FIXATION METHOD WERE LISTED. UNIVARIATE AND MULTIVARIATE ANALYSES WERE PERFORMED TO IDENTIFY RISK FACTORS ASSOCIATED WITH PERSISTENT NONUNION. NONUNION FACTORS CAN BE GROUPED INTO TWO GENERAL CATEGORIES: BIOLOGICAL AND BIOMECHANICAL. BIOLOGICAL FACTORS INCLUDE SMOKING, BLOOD FLOW, AND THE TIME FROM INJURY, WHILE BIOMECHANICAL FACTORS INCLUDE CHARACTERISTICS OF THE FRACTURE SITE AND THE FIXATION METHOD. IN THE PRESENT STUDY, SMOKERS TENDED TO HAVE LOWER UNION RATES, BUT THE DIFFERENCE WAS NOT SIGNIFICANT. THE AUTHORS CONCLUDED THAT WHILE TREATMENT METHODS FOR SCAPHOID NONUNION HAS IMPROVED, IT IS STILL A CLINICAL PROBLEM ESPECIALLY WHEN THE PROXIMAL BONE FRAGMENTS ARE SMALL. UNDERSTANDING THE CHARACTERISTICS OF THESE SMALL PROXIMAL FRAGMENT SHOULD BE CONSIDERED WHEN TREATING PERSISTENT SCAPHOID NONUNION COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153105 ACUTRAK SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R