BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW 18MM

    MDR report key: 3962112 · Received July 28, 2014

    Report

    Report Number
    3009450884-2014-10046
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    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 COMMON DEVICE NAME HWC. NO NONCONFORMANCE 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE SCREW IS BROKEN AT THE SECOND THREAD FROM SCREW HEAD WITH ONLY 4MM RETURNED. THE REMAINING 14MM WAS LEFT IN PATIENT AS PER DETAILS IN DEVICE REPORT. IT WAS REPORTED THAT THE PLATE WAS BENT TO FIT TO THE BONE, WHEN THE SCREW HEAD BROKE OUT. IT¿S NOT CLEAR IF THE SCREW WAS ALREADY IN THE PLATE WHEN THIS WAS DONE. THE SCREWS ARE DESIGNED TO BE INSERTED STRAIGHT INTO THE PLATE AND IF THE PLATE WAS BENT WHILE THE SCREWS WERE IN THE PLACE OR TORSION WAS APPLIED TO THE SCREWS AT AN ANGLE, THIS WOULD CAUSE BREAKAGE. A THOROUGH INVESTIGATION WAS CONDUCTED AND THIS LOT NUMBER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 DURING AN ELBOW FRACTURE TREATMENT THE SURGEON WAS APPLYING A STEEL RECON PLATE AND BENT THE PLATE TO FIT INTO THE BONE WHILE INSERTING THE SCREW ONE OF THE SCREW HEADS BROKE OUT. NO PATIENT HARM. SCREW WAS LEFT IN PLACE AS IT WAS IN THE PLATE AND BONE. AN IMAGE READING OF THE THREE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER AND REPORTED THE FOLLOWING: ASSOCIATE MEDICAL DIRECTOR REVIEWED THE COMPLAINT DESCRIPTION AND X-RAY IMAGES AND CAN¿T VERIFY THE SCREW HEAD BREAKAGE DESCRIPTION FROM THE PROVIDED X-RAY IMAGES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438058 3.5MM CORTEX SCREW 18MM PLATE, FIXATION, BONE HRS SYNTHES GRENCHEN 8619368

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR