BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CORTEX SCREW 32MM

    MDR report key: 3982694 · Received August 6, 2014

    Report

    Report Number
    3009450884-2014-10047
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HRS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE CAUSE OF THE FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES, THE REASON FOR A BREAKAGE IS THE INSERTION WITHOUT PRE DRILLING AND/OR TOO MUCH APPLIED MECHANICAL FORCE HAS RESULTED IN THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED. 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: THE SCREW WAS INSERTED WITHOUT PREDRILLING AND BROKE AT THE SCREW HEAD. THIS HAPPENED DURING OPERATION, NO RESIDUE IN PATIENT AND THE BROKEN SCREW WAS REMOVED WITH SCREW EXTRACTION SET. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459400 3.5MM TI CORTEX SCREW 32MM SCREW,FIXATION,BONE HWC SYNTHES GRENCHEN 8961419

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR