BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW 42MM

    MDR report key: 5967241 · Received September 21, 2016

    Report

    Report Number
    3009417901-2016-10035
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 23, 2016 REGARDING LOT NUMBER AND REPORTING FACILITY CONTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 9823467. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: FEB 1, 2016. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS ATTEMPTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: PART: ARTICLE AND LOT NUMBER DO NOT MATCH THEREFORE NOT ABLE TO REVIEW DHR 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. THE VISUAL INSPECTION SHOWED THAT THE SCREWS ARE BROKEN JUST BELOW THE SCREW HEADS. THE REMAINING SCREW BODIES WERE NOT RETURNED FOR EVALUATION. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT PART NO. 214.040 WAS MANUFACTURED IN FEBRUARY 2016 AND PART NO. 214.042 WAS MANUFACTURED IN SEPTEMBER 2015 IN ACCORDANCE WITH ALL ESTABLISHED REQUIREMENTS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. AN EXACT ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED AS SPECIFIC DETAILS WERE NOT PROVIDED. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THIS COMPLAINT CONDITION IS LIKELY A RESULT OF METHOD OF USE. 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

    IT WAS REPORTED THAT DURING THE SURGERY THE SCREW HEADS WERE BROKEN. THIS COMPLAINT INVOLVES 2 PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618243 4.5MM CORTEX SCREW 42MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 9823467

    Patients

    Seq Age Sex Outcome Treatment
    1