BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 6014793 · Received October 10, 2016

    Report

    Report Number
    3000270450-2016-10242
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: WE HAVE RECEIVED ONE OUT OF FOUR SCREWS OF ARTICLE 04.503.104.04S FOR INVESTIGATION. MICROSCOPIC EXAMINATION OF THE COMPLAINED SCREW SHOWS THAT THE THREAD TIP IS FLATTENED AND THE FIRST FLANK IS CRACKED WITHOUT FRAGMENTATION. THE RECESS HOWEVER IS IN GOOD CONDITION WITH SLIGHT SIGNS OF USAGE. THE COMPLAINT CONDITION OF A BROKEN SCREW HEAD COULD NOT BE PROVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED LOT NUMBER L018890 WAS RESEARCHED AND NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE WHILST INSERTING INTO THE BONE, FOR EXAMPLE BY AN EXCESSIVE CONTACT WITH THE PLATE, CAUSED THE TIP DAMAGE. AS THESE SCREWS ARE VERY SMALL AND QUITE FRAGILE, A LOT OF CARE IS REQUIRED WHILE HANDLING. WE CAN CONFIRM THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON CONFORMITY. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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 NUMBER PROVIDED IS FOR A 4 PACK OF SCREWS; PER REPORTED EVENT, ONLY 1 SCREW IN THE PACK WAS INVOLVED IN THE COMPLAINED EVENT. (B)(4). DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). STERILE PART 04.503.104.04S, LOT L018890: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 13, 2016. EXPIRY DATE: JUNE 01, 2026. ARTICLE WAS STERILIZED BY SUPPLIER (B)(4). NON-STERILE PART 04.503.104.04, LOT H061571: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MARCH 17, 2016. 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 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON WAS UNABLE TO INSERT A SCREW BECAUSE THE SCREW HEAD WAS BROKEN. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666186 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES SELZACH L018890

    Patients

    Seq Age Sex Outcome Treatment
    1