BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 4628533 · Received March 24, 2015

    Report

    Report Number
    1719045-2015-10185
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    February 13, 2015
    Report Date
    March 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE 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.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: NO MATERIAL RECEIVED FOR INVESTIGATION, SO DETERMINATION OF POTENTIAL CORRECTIVE ACTION IMPOSSIBLE. BECAUSE OF MISSING MATERIAL AND REQUESTED ADDITIONAL INFORMATION ONLY A DHR REVIEW WAS CONDUCTED. ART. NO.: 04.503.104.01C, LOT NO.: 7935250, AT NEU SCREW Ø1.5 SELF-DRILL L4 TAN 1U I/C. THIS LOT WAS MANUFACTURED IN FEBRUARY 2015, ALL PARTS ACCORDING TO OUR SPECIFICATIONS. ALL DEVICES WERE DISTRIBUTED AND WE ARE NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT. 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 TWO MATRIXNEURO 4MM AND 5MM SCREWS WERE BROKEN WHEN THE SURGEON TRIED TO IMPLANT THEM INTO THE PATIENT. IT WAS STATED THAT TWO BROKEN SCREWS WERE INVOLVED IN THIS COMPLAINT, BUT NOT KNOWN WHICH TWO. THERE WAS NO PATIENT HARM REPORTED AND NO PROLONGATION OF SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195640 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES MONUMENT 7935250

    Patients

    Seq Age Sex Outcome Treatment
    1