BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI STERNAL LOCKING X PLATE 10 HOLES

    MDR report key: 6759648 · Received August 2, 2017

    Report

    Report Number
    3003506883-2017-10148
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 4, 2017
    Report Date
    July 4, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: HWC, JDQ. (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS PART WAS DISCARDED BY THE FACILITY. (B)(6). 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A RIB FRACTURE FIXATION INCLUDING STERNAL FRACTURE PLATING SURGERY PERFORMED ON (B)(6) 2017, THE STERNAL BODY PLATE PIN SNAPPED/BROKE AS THE SURGEON WAS BENDING THE PLATE. THE PIN COMES WITH THE PLATE. THE SURGEON TRIED TO REMOVE THE PIN IN ORDER TO REPLACE THE PIN, BUT THE PIN WAS STUCK IN THE PLATE, AND THE PIN PROCEEDED TO BREAK INTO SMALL PIECES AS THE SURGEON TRIED TO REPLACE IT. THEREFORE, THE PLATE BECAME REDUNDANT AND AFTER FIFTEEN (15) MINUTES OF TRYING TO REMOVE THE PIN, SURGEON DECIDED TO USE ANOTHER PLATE, AND DISCARD THE PLATE WITH THE BROKEN PIN STILL INSIDE. ALL BROKEN PIECES OF THE PIN WERE REMOVED FROM THE WOUND. NO REPORTED ADVERSE EVENT TO PATIENT. THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING X PLATE 10 HOLES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542726 TI STERNAL LOCKING X PLATE 10 HOLES PLATE,FIXATION,BONE HRS SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1