BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 6866387 · Received September 14, 2017

    Report

    Report Number
    1719045-2017-10912
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 24, 2017
    Report Date
    August 24, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S DATE OF BIRTH OR AGE, GENDER AND WEIGHT ARE NOT PROVIDED FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE: HRS. THIS REPORT IS FOR TWO (2) LOCKING SCREWS. THE FOLLOWING THREE PARTS NUMBERS FOR THE SCREW ARE REPORTED; HOWEVER, IT IS UNKNOWN WHICH TWO SCREWS OUT OF THESE THREE PARTS NUMBERS WOULD NOT LOCK INTO THE PLATE. THE 02.211.020: 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20 MM, (B)(4). THE 02.211.018: .7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18 MM, (B)(4). THE 02.211.016: .7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16 MM, (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 EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    IT WAS REPORTED THAT DURING A RIGHT ELBOW PROCEDURE ON (B)(6) 2017 THE SURGEON PLACED A VARIABLE LOCKING DISTAL HUMERAL PLATE INTO PATIENT. SURGEON COULD LOCK ONE VARIABLE LOCKING SCREW INTO THE PLATE. WHEN SURGEON TRIED THE TO LOCK THE NEXT TWO VARIABLE LOCKING SCREWS INTO THE PLATE THEY WOULD NOT LOCK. SURGEON THEN REMOVED ALL HARDWARE (ONE PLATE AND THREE SCREWS) AND IMPLANTED THE PATIENT WITH A COMPETITOR¿S DEVICES. THERE WAS A TWENTY TO TWENTY-FIVE-(25) MINUTE DELAY IN SURGERY. THE PATIENT¿S OUTCOME IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: 2.7 MM/3.5 MM VA-LCP LAT DSTL HUM PL (PART # 02.117.802S, LOT # 7854767, QUANTITY 1) VA LOCKING SCREW (QUANTITY 1). THIS REPORT IS FOR TWO (2) UNKNOWN LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645336 SCREW,FIXATION,BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention