BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3873018 · Received June 13, 2014

    Report

    Report Number
    2520274-2014-11809
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NO DIAGNOSIS. ALQUEAZA, A., MUDGAL, C., & NEUHAUS, V. (2012) OPEN REDUCTION AND TEMPORARY INTERNAL FIXATION OF A SUBACUTE ELBOW DISLOCATION. J. HAND SURG. 2012; 37A: 1011-1014. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OPEN REDUCTION AND TEMPORARY INTERNAL FIXATION OF A SUBACUTE ELBOW DISLOCATION. ALQUEAZA, A, MUDGAL, C., NEUHAUS, V. (2012) OPEN REDUCTION AND TEMPORARY INTERNAL FIXATION OF A SUBACUTE ELBOW DISLOCATION. J. HAND SURG. 2012; 37A: 1011-1014. THIS WAS A RETROSPECTIVE ANALYSIS OF ONE (B)(6) FEMALE PATIENT AND UNCOMMON SUBACUTE OR CHRONIC ELBOW DISLOCATION. THE PATIENT SUSTAINED A DISLOCATION OF THE RIGHT ELBOW AFTER A FALL. ONE MONTH AFTER THE INJURY, SHE PRESENTED TO THE HOSPITAL. THE PATIENT UNDERWENT OPEN REDUCTION, DECOMPRESSION OF THE ULNAR NERVE, AND GRANULATION TISSUE REMOVAL OF THE JOINT. TREATMENT INCLUDED A TITANIUM, 16-HOLE, 3.5-MM LC-DCP PLATE WHICH WAS CONTOURED AND PLACED PROXIMALLY TO THE HUMERUS AND DISTALLY TO THE ULNA. AFTER SUCCESSFUL CLOSURE, THE PATIENT'S RIGHT UPPER LIMB WAS PLACED IN A PLASTER OF PARIS SPLINT. ULNAR NERVE SYMPTOMS RESOLVED WITHIN TWO WEEKS. THE PLATE WAS REMOVED FOUR WEEKS AFTER SURGERY WITHOUT MANIPULATING THE ELBOW. THERAPY WAS INITIATED WITH SHORT-ARC RANGE OF MOTION IN THE NEXT TWO WEEKS; THIS WAS ACCOMPANIED BY INTERMITTENT SUPPORT WITH A LONG-ARM POSTERIOR SPLINT. LATER, ONE YEAR AFTER INJURY, THE PATIENT WAS RE-EVALUATED. THE ELBOW WAS STABLE TO VALGUS AND VARUS STRESS IN NEARLY FULL EXTENSION; HOWEVER, THE ELBOW LACKED 20% OF EXTENSION BUT HAD FULL FLEXION. FOREARM ROTATION AND NEUROLOGIC FUNCTION WERE FULL. THE PATIENT ALSO REPORTED OCCASIONAL ELBOW ACHE WHICH DID NOT REQUIRE MEDICATION. ANTERIOR AND LATERAL RADIOGRAPHS DEMONSTRATED MAJOR DEGENERATIVE CHANGES IN THE ULNOHUMERAL JOINT, A BROKEN SCREW IN THE HUMERUS, POSTERIOR SUBLUXATION OF THE ULNOHUMERAL JOINT, ANTERIOR SUBLUXATION OF THE RADIAL HEAD, AND HETEROTOPIC OSSIFICATION. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349403 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR