BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4962380 · Received August 3, 2015

    Report

    Report Number
    2520274-2015-15107
    Event Type
    Injury
    Date Received
    August 3, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE PRODUCT CODE IS HRS. THIS REPORT IS FOR ONE, UNKNOWN LOCKING SCREW. THE PART NUMBER WAS REPORTED TO BE EITHER 02.211.054, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 54MM, 510(K) K100776, DEVICE PRODUCT CODES HRS AND HWC, OR 02.211.056, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 56MM, 510(K) K100776, DEVICE PRODUCT CODES HRS AND HWC. LOT NUMBERS WERE NOT PROVIDED AND ARE UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    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

    THIS REPORT IS FOR ONE UNKNOWN LOCKING SCREW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE TO TREAT A LEFT SUPRACONDYLAR HUMERUS FRACTURE WITH AND UNKNOWN NUMBER OF SCREWS AND TWO PLATES ON (B)(6) 2015. THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT ON UNKNOWN DATE AFTER IMPLANT SURGERY. THE PATIENT REPORTED BLISTERING AND A SCREW HEAD PROTRUDING OVER LATERAL ASPECT OF ELBOW FOLLOWING MOTOR VEHICLE ACCIDENT. THE PATIENT RETURNED TO OPERATING ROOM ON (B)(6) 2015 FOR REMOVAL OF THE PROTRUDING LOCKING SCREW. A WOUND CULTURE WAS ALSO TAKEN DURING THE REVISION SURGERY. ON (B)(6) 2015 THE CULTURE RESULTS WERE DETERMINED TO BE POSITIVE FOR INFECTION; HOWEVER, THE TYPE OF ORGANISM UNKNOWN. THE PATIENT DID NOT FOLLOW UP WITH RECOMMENDATION FOR ANTIBIOTIC THERAPY AND RETURNED TO SURGEON OFFICE ON (B)(6) 2015, WITH DRAINING PUS FROM WOUND. AN X-RAY TAKEN ON (B)(6) 2015 REVEALED A BROKEN LOCKING SCREW. THE PATIENT RETURNED TO THE OPERATING ON (B)(6) 2015 AND HAD LOCKING SCREW AND TWO PLATES REMOVED DUE TO BROKEN LOCKING SCREW, INFECTION AND LOSS OF REDUCTION. THE PATIENT WAS RE-PLATED SUCCESSFULLY. THERE WAS NO FURTHER PATIENT HARM OR ADDITIONAL INFORMATION REPORTED. THIS REPORT ADDRESSES THE FIRST REVISION SURGERY INVOLVING THE REMOVAL OF THE PROTRUDING LOCKING SCREW. THE SECOND REVISION SURGERY AND EVENTS ARE ADDRESSED AND REPORTED UNDER A SEPARATE COMPLAINT NUMBER (B)(4). THIS REPORT IS FOR ONE UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504240 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention