BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI LOCKING SCREW SELF-TAPPING 45MM

    MDR report key: 5077316 · Received September 15, 2015

    Report

    Report Number
    2520274-2015-15875
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: WE HAVE RECEIVED FOUR LOCKING-SCREWS FOR EVALUATION, BUT THE PLATE WE HAVE NOT RECEIVED FOR INVESTIGATION. ALL SCREWS ARE THE THREAD DAMAGED AT THE HEAD AND SHAFT. OUR REVIEW OF THE RECEIVED X-RAYS HAS SHOWN, THAT WE CAN¿T CONFIRM THE INTRAOPERATIVE SCREW THREAD PEELING-OFF AS REPORTED IN THE DESCRIPTION. THE DEVICE HISTORY RECORDS FOR THESE ARTICLES AND LOT NUMBERS WERE REVIEWED AND THOSE WERE MANUFACTURED ACCORDING TO SPECIFICATIONS IN BETWEEN DECEMBER 2013 AND SEPTEMBER 2014 WITH NO ISSUES OR DEVIATIONS DURING THE PROCESS. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS REPORTED PROBLEM, BUT, IT IS LIKELY THAT THE SCREWS GOT IN CONTACT WITH HARD MATERIAL AS THE PLATE AND/OR THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. NO PRODUCT FAULT COULD BE DETECTED. 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

    (B)(6). DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(6) WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    PART 413.045-CX, LOT 9083809: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 27JULY2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON HAD INSERTED 3.5MM LOCKING SCREWS IN THE PLATE AND AFTER HE OBSERVED THAT SCREW LENGTH WAS NOT CORRECT. HE THEN DECIDED TO REMOVE THE SCREWS. WHILE REMOVING THE LOCKING SCREWS, THE OUTER THREADING PEALED OUT; THIS HAPPENED WITH FOUR (4) LOCKING SCREWS. IT WAS REPORTED THERE WAS A FIFTEEN (15) MINUTE DELAY IN THE PROCEDURE. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608085 3.5MM TI LOCKING SCREW SELF-TAPPING 45MM APPLIANCE, FIXATION, NAIL KTT SYNTHES HAGENDORF 9083809

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR