BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 4393579 · Received January 7, 2015

    Report

    Report Number
    2530088-2015-10012
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    December 11, 2014
    Report Date
    December 11, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFYING INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES USED IN THIS REPORT INCLUDE: MNH, MNI, KWQ, AND KWP. IT IS UNKNOWN IF THE COMPLAINANT PART IS FROM LOT 8943434 OR LOT 9034575. DEVICE WAS NOT EXPLANTED; REMAINS IN PATIENT. DEVICE IS NOT BEING RETURNED AS IT REMAINS IN THE PATIENT. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW(S): LOT 7562236 - MANUFACTURE DATE: DECEMBER 19, 2013: REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 7655115 - MANUFACTURE DATE: APRIL 4, 2014: REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BOTH LOTS WERE ONLY PACKED AND STERILIZED AT SYNTHES (B)(4). REVIEW OF THE DHRS SHOWED THAT THERE WERE NO ISSUES DURING THE PACKAGING OR STERILIZATION OF THE PRODUCTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 EVEN IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON PARTIALLY TIGHTENED THE MATRIX LOCKING CAP WITH THE GREEN HANDLE T25 SCREW DRIVER. THE LOCKING CAP BECAME FASTENED TIGHT INTO THE HEAD OF THE SCREW. THE LOCKING CAP COULD NOT BE REMOVED OR TIGHTENED FURTHER. ATTEMPTS TO REMOVE THE LOCKING CAP WITH GREEN HANDLE T25, LONG T25 WITH GREEN RING, AND LONG T25 SCREW DRIVERS RESULTED IN THE SHEARING OF THE TIPS OF EACH. ALL THREE SCREW DRIVER TIPS NOW SLIP WHEN ATTEMPTING TO TIGHTEN A LOCKING CAP. THE LOCKING CAP IN QUESTION HAS A WORN INNER NUT WHICH CANNOT BE RELEASED. THE LOCKING CAP REMAINS IN THE PATIENT AS THE SURGEON COULD NOT REMOVE IT. THE SURGERY WAS PROLONGED BY 15MINS. NO REPORTED PATIENT HARM. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13262 TI MATRIX LOCKING CAP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1