BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM

    MDR report key: 3988158 · Received August 7, 2014

    Report

    Report Number
    3000270450-2014-10071
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A 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. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART 212.818 LOT 8790511 WERE REVIEWED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER DID NOT FIT INTO THE HEAD OF THE SCREWS DURING A PROCEDURE. THERE WAS A TEN TO FIFTEEN MINUTE DELAY IN THE PROCEDURE WHILE A NEW SCREWDRIVER AND SCREWS WERE OPENED. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464055 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM PLATE, FIXATION, BONE HRS SYNTHES SELZACH 8797533

    Patients

    Seq Age Sex Outcome Treatment
    1