BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 3891622 · Received June 24, 2014

    Report

    Report Number
    9612488-2014-10242
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    PMA / PMN Number
    PK042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: BOTH SCREWS SHOW SIGNS OF USAGE. EXAMINATION OF ONE OF THE SCREWS SHOWS TRACES OF BONE RESIDUE. THE TIP OF THIS SCREW IS COMPLETELY BROKEN OFF. THE OTHER SCREW SHOWS SIGNS OF USAGE AS SMALL AMOUNT OF BONE RESIDUE VISIBLE, BUT THE TIP IS IN GOOD CONDITION. AS 2 SCREWS FROM DIFFERENT LOT NUMBERS WERE RETURNED, CANNOT DETERMINE WHICH SCREW CAME FROM WHICH LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH SCREWS WAS CONDUCTED AND THESE LOTS WERE MANUFACTURED TO DRAWING AND SPECIFICATIONS. LOT 8721152 WAS MANUFACTURED IN NOVEMBER 2013 AND LOT 8798651 WAS MANUFACTURED IN JANUARY 2014. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE WHILE INSERTING THE SCREW INTO THE BONE CAUSED THE TIP BREAKAGE OF THE SCREW. AS THE SCREWS ARE VERY SMALL AND FRAGILE, A LOT OF CARE IS REQUIRED WHILE HANDLING. 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

    DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. 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 THE TIP OF THE SCREWS WERE BROKEN EASILY. SINCE THIS OCCURRED ON TWO SCREWS IN A ROW, THE SURGEON DECIDED TO DISPOSE THE REST OF THE SCREWS. THIS OCCURRED DURING SURGERY. THERE WAS NO REPORTED DELAY IN THE PROCEDURE AND NO REPORTED PATIENT HARM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368527 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE HWC SYNTHES BETTLACH 8798651

    Patients

    Seq Age Sex Outcome Treatment
    1