BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 24MM F/IM NAILS-STER

    MDR report key: 4257980 · Received November 18, 2014

    Report

    Report Number
    3000270450-2014-10151
    Event Type
    Injury
    Date Received
    November 18, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART, PART 04.005.414 LOT 8864776, WERE REVIEWED WITH THE FOLLOWING RESULT: NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2014, THE MULTILOCK HUMERAL NAILING SYSTEM WAS USED FOR THREE-PART PROXIMAL HUMERUS FRACTURE, AND SCREWS IN SCREWS WERE INSERTED AT PROXIMAL REGION. THE PATIENT STARTED HIS REHABILITATION SUCH AS LIGHT MOTION OF PENDULUM FROM A WEEK AFTER OF THE FIRST SURGERY. ON (B)(6), IT WAS FOUND THAT THE GREATER TUBERCLE BONE FRAGMENT WAS DISLOCATED AT UPWARD OF PROPER POSITIONING THOROUGHLY OVER THE TRANSVERSE NAIL HEAD. ON (B)(6) 2014, THE RE-SURGERY WAS PERFORMED. THE SURGEON SUTURED THE PATIENT¿S THE GREATER TUBERCLE BONE FRAGMENT TOGETHER WITH HIS ROTATOR CUFF AND FIXED THE POSITION WITH TIGHTENING TO THE SUTURE HOLE AND COMPLETED THE SURGERY. THE PATIENT SHOWED INVOLUNTARY MOVEMENT AND MUSCLE STIFFNESS DUE TO PARKINSON DISEASE. THIS REPORT IS 2 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744302 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 24MM F/IM NAILS-STER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SELZACH 8907385

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention