BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 5651033 · Received May 12, 2016

    Report

    Report Number
    2520274-2016-12672
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 25, 2016
    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

    (B)(4). (B)(6). PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED . 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

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: DECEMBER 21, 2015. PART (B)(4), LOT 9964555: 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. A PRODUCT INVESTIGATION WAS COMPLETED: ONLY THE BROKEN OFF SCREW HEAD WAS RECEIVED FOR EVALUATION. THE SHAFT WITH THE THREAD WAS NOT INCLUDED. THEREFORE, NO MEASURING OF THE DIMENSIONS IS POSSIBLE. MICROSCOPIC INVESTIGATION SHOWS STRONG MECHANICAL DAMAGES AT THE CRUCIFORM RECESS OF THE SCREW HEAD. THE RECESS IS PLASTICALLY DEFORMED WHAT INDICATES EXCEEDING APPLIED MECHANICAL FORCE WHILE INSERTION. AS NO MANUFACTURING RELATED ISSUE COULD BE IDENTIFIED, MECHANICAL OVERLOADING WAS IDENTIFIED AS ROOT CAUSE. NO INDICATION FOR MATERIAL, MANUFACTURING OR DESIGN 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

    (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BASED ON THE COMPLAINT DESCRIPTION, WITHOUT MATERIAL, NO FURTHER INVESTIGATION IS POSSIBLE. WITH UNKNOWN LOT NUMBER, DHR REVIEW IS IMPOSSIBLE. (B)(6). 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 A MATRIXNEURO SCREW BROKE DURING SURGERY ON (B)(6) 2016. THERE WAS NO REPORTED SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    (B)(4): E-MAIL DATED THAT (B)(6) 2016 STATES THAT ONLY THE TIP OF THE SCREW BROKE AND NO FRAGMENTS WERE GENERATED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NEW EVENT DESCRIPTION: "(B)(6) YEAR-OLD FEMALE PATIENT WITH (B)(6). SET CRANIOTOMY WITH CLIPPING ANEURYSM SURGERY ON (B)(6) 2016 AT 12:00. DOCTORS CLOSED THE SKULL BY PLATE WITH MATRIX MIDFACE SCREW 1.5 ST LONG 4MM AT 2:00 PM. DURING THE SURGERY, DOCTORS SCREWS ON THE TABLE IN PREPARATION TO CLOSE THE SKULL BONE BUT IT TURNS OUT THAT THE SCREW HEAD WAS BROKEN AND TORN. MATERIAL WON'T BE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305988 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES MONUMENT 9964555

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR