BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3944942 · Received July 18, 2014

    Report

    Report Number
    2520274-2014-12712
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE UNKNOWN PLATE. DEVICE HAS NOT BEEN EXPLANTED. 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.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS REPORTED DUE TO TWO DISTAL LOCKING SCREWS THAT BACKED OUT OF THE PATIENT¿S PLATE. DURING THE REVISION, THE SURGEON HAD TROUBLE ENGAGING THREE OF THE LOCKING HOLES ON TWO OF THE PLATES TO WHICH THE PATIENT WAS REVISED. THE PATIENT WAS ORIGINALLY TREATED FOR A DISTAL HUMERUS FRACTURE ON AN UNKNOWN DATE WITHIN THE FIVE WEEKS PRIOR TO THIS REPORT. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT FELL AND WENT TO SEE THE SURGEON. THE SURGEON CONFIRMED VIA X-RAY THAT THE PATIENT¿S CONSTRUCT COLLAPSED DUE TO TWO DISTAL LOCKING SCREWS THAT BACKED OUT OF THE TWO MOST DISTAL LOCKING HOLES; THEY WERE NOT ENGAGED. THE SURGEON EXPLANTED ALL OF THE PATIENT¿S HARDWARE AND REVISED HER TO THREE NEW PLATES. DURING THE REVISION, THE SURGEON PLACED A POSTERIOR LATERAL DISTAL HUMERUS PLATE, A MEDIAL PLATE, AND AN OLECRANON PLATE. IT WAS REPORTED THAT THE SURGEON HAD TROUBLE ENGAGING THE MOST DISTAL LOCKING HOLE ON THE MEDIAL PLATE. THE SURGEON ALSO HAD TROUBLE ENGAGING THE TWO MOST PROXIMAL HOLES ON THE OLECRANON PLATE, BUT WAS EVENTUALLY ABLE TO ENGAGE ONE OF THEM. THE SURGEON WAS NOT ABLE USE ONE LOCKING HOLE ON EACH PLATE. THERE WAS A 15 MINUTE DELAY IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE UNKNOWN OLECRANON PLATE. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421658 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR