BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URS Ø7 L45

    MDR report key: 3922335 · Received July 9, 2014

    Report

    Report Number
    1000562954-2014-10113
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED PART HAS BEEN REINSPECTED AND ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION. BUSHING AND DOUBLE SD25 SCREW DAMAGED POST PRODUCTION. NO EVIDENCE OF NONCONFORMANCE MANUFACTURING RELATED. 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 (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 DURING THE SURGERY THE SURGEON WAS TRYING TO REDUCE INTO THIS PARTICULAR SCREWS. DURING THIS MANOEUVRE THE HEAD OF THE UNIVERSAL REDUCTION SCREW (URS) DISLODGED AND POPPED OFF. THERE WAS NO PATIENT THERE WAS SURGICAL DELAY OF THIRTY MINUTES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399259 URS Ø7 L45 SCREW, FIXATION, BONE HWC SYNTHES MEZZOVICO 8938949

    Patients

    Seq Age Sex Outcome Treatment
    1