BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW 38MM

    MDR report key: 3900341 · Received June 27, 2014

    Report

    Report Number
    3009450884-2014-10028
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE BROKE WHILE BEING INSERTED; IT WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS 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. 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 DURING A TRAUMA PROCEDURE WHILE APPLYING FORCE TO SCREW THE SCREW INTO THE BONE THE HEAD OF THE SCREW SHEARED OFF. THE SHAFT OF THE SCREW WAS LEFT IN PATIENT WITH NO ADVERSE EFFECT. THE PROCEDURE COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376848 4.5MM CORTEX SCREW 38MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 8623125

    Patients

    Seq Age Sex Outcome Treatment
    1