BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIRE, SURGICAL

    MDR report key: 3816291 · Received May 16, 2014

    Report

    Report Number
    2520274-2014-11352
    Event Type
    Injury
    Date Received
    May 16, 2014
    Report Date
    April 26, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SURGICAL TREATMENT OF DISTAL RADIAL FRACTURES WITH A VOLAR LOCKING PLATE VERSUS CONVENTIONAL PERCUTANEOUS METHODS. J BONE JOINT SURG AM. 2013;95:1737-44. THIS REPORT IS FOR UNKNOWN WIRES. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. SURGICAL TREATMENT OF DISTAL RADIAL FRACTURES WITH A VOLAR LOCKING PLATE VERSUS CONVENTIONAL PERCUTANEOUS METHODS. ALEXIA KARANTANA, FRCS(ORTH), NICHOLAS D. DOWNING, FRCS(ORTH), DAREN P. FORWARD, FRCS(ORTH), DM, MARK HATTON, FRCS(ORTH), ANDREW M. TAYLOR, FRCS(ORTH), DM, BRIGITTE E. SCAMMELL, FRCS(ORTH), DM, CHRIS G. MORAN, FRCS(ED), DM, AND TIM R.C. DAVIS, FRCS. J BONE JOINT SURG AM. 2013;95:1737-44. A SINGLE-CENTER, PRAGMATIC, RANDOMIZED CONTROLLED TRIAL WAS CONDUCTED IN A TERTIARY CARE INSTITUTION. ONE HUNDRED AND THIRTY PATIENTS (EIGHTEEN TO SEVENTY-THREE YEARS OF AGE) WHO HAD A DISPLACED DISTAL RADIAL FRACTURE WERE RANDOMIZED TO TREATMENT WITH EITHER A VOLAR LOCKING PLATE OR A CONVENTIONAL PERCUTANEOUS FIXATION METHOD. INSTRUMENTATION USED IN THE CONTROL GROUP INCLUDED SMOOTH 1.6-MM KIRSCHNER WIRES AND A SUPPLEMENTAL STANDARD AO/ASIF EXTERNAL FIXATOR (SYNTHES, (B)(4)), FOR 67 PATIENTS. THE PERCUTANEOUS KIRSCHNER WIRES BECAME INADVERTENTLY BURIED IN SIX PATIENTS, REQUIRING REMOVAL WITH USE OF A LOCAL ANESTHETIC. ONE PATIENT WHO DEVELOPED CARPAL TUNNEL SYNDROME THREE MONTHS FOLLOWING INJURY REQUIRED MEDIAN-NERVE DECOMPRESSION. ANOTHER PATIENT SUSTAINED AN EXTENSOR POLLICIS LONGUS RUPTURE AND LATER REQUIRED RECONSTRUCTION. HE HAD BEEN RANDOMIZED TO THE CONTROL GROUP BUT UNDERWENT VOLAR LOCKING PLATE FIXATION AT HIS SURGEON¿S DISCRETION, AFTER USE OF KIRSCHNER WIRES FAILED TO ACHIEVE AN ACCEPTABLE INTRAOPERATIVE RESULT. THIS REPORT IS FOR UNKNOWN K-WIRES FOR BURIED K-WIRES IN 6 PATIENTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294021 WIRE, SURGICAL LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention