BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 19281825 · Received May 9, 2024

    Report

    Report Number
    3025141-2024-00382
    Event Type
    Injury
    Date Received
    May 9, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS 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.

    Description of Event or Problem · 0

    IN THE ARTICLE "RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON INVOLVED BETWEEN THE RADIAL SHAFT AND THE VOLAR LOCKING PLATE" BY HIRAISHI, Y., ET AL, THE AUTHORS PRESENTED A RARE CASE OF FLEXOR POLLICIS LONGUS (FPL) TENDON RUPTURE DUE TO THE INVOLVEMENT OF THE FPL TENDON IN THE SPACE BETWEEN THE VOLAR LOCKING PLATE (VLP) AND THE RADIAL SHAFT A MONTH AFTER SURGERY. THIS WAS A CASE REPORT. PATIENT WAS A 61-YEAR-OLD RIGHT-HANDED FEMALE WITH A BODY MASS INDEX OF 30.04 (HEIGHT: 158 CM; WEIGHT: 75 KG) FELL ON HER RIGHT HAND AND SUSTAINED A VOLAR BARTON FRACTURE OF THE DISTAL RADIUS, WHICH WAS SURGICALLY TREATED USING A VLP (ACU-LOC 2 VOLAR DISTAL RADIUS PLATE; ACUMED, HILLSBORO, OR). ONE MONTH POSTOPERATIVELY, SHE WAS UNABLE TO FLEX HER THUMB AND RUPTURE OF THE FPL WAS CONFIRMED WITH MAGNETIC RESONANCE IMAGING. TREATMENT OF FPL TENDON RUPTURE WAS DONE AT THE TIME OF PLATE REMOVAL 5 MONTHS AFTER THE INITIAL OPERATION. DURING SURGERY THE PROXIMAL STUMP OF THE RUPTURED FPL TENDON WAS INVOLVED (SANDWICHED) BETWEEN THE RADIAL SHAFT AND ULNAR SIDE OF THE PLATE. PER THE AUTHORS, THIS MAY HAVE BEEN DUE TO THE FLOATING SETTING OF THE VLP TO THE RADIAL SHAFT. AFTER THE PLATE REMOVAL, THE RUPTURED FPL TENDON WAS RECONSTRUCTED BY THE IPSILATERAL PALMARIS LONGUS (PL) TENDON GRAFT. THE WRIST WAS PLACED IN A SHORT ARM SPLINT WITH THE WRIST AND METACARPOPHALANGEAL (MP) JOINT OF THE THUMB SLIGHTLY FLEXED FOR 3 WEEKS, WHILE THE INTERPHALANGEAL (IP) JOINT OF THE THUMB WAS ALLOWED FOR ACTIVE MOTION. PER THE AUTHORS, THE PATIENT SHOWED EXCELLENT RECOVERY 9 MONTHS POSTOPERATIVELY AND DEMONSTRATED RESTORED GRIP STRENGTH, KEY PINCH, AND FULL RANGE OF MOTION OF THE WRIST WITHOUT ANY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751763 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other