BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 16029202 · Received December 21, 2022

    Report

    Report Number
    8030965-2022-11377
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 30, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    UDI-DI
    10887587018324
    PMA / PMN Number
    K123723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: DATE OF EVENT: DATE OF EVENT IS REPORTED AS PRIOR TO (B)(6) 2022. PROCODE: ADDITIONAL PRO-CODES: GXO, GWO DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 14-JUL-2022 PART NUMBER: 04.503.104.01, TI MATRIXNEURO SCREW SELF- DRILLING 4MM LOT NUMBER: 928P411 (NON-STERILE) LOT QUANTITY: 348 AT ONE PIECE WAS SCRAPPED FOR BEING UNDER COUNT FOR QUANTITY AND ANOTHER PIECE WAS SCRAPPED FOR AGAIN BEING UNDER COUNT. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT DIMENSIONAL / FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 21015, TIALNBRRRI4.00-PHI LOT NUMBER: 424P645 LOT QUANTITY: 1,527 LBS. INSPECTION INSTRUCTION DATED 23-SEP-2021 MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFIED TEST REPORT RECEIVED FROM PERRYMAN COMPANY DATED 28-SEP-2021 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 30-SEP-2021 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY REVIEW THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE 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. B5: UPDATED EVENT DESCRIPTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SURGEON HAD A MATRIX NEURO SCREW TIP BREAK OFF INTO A PTS SKULL WHILE INSERTING THE SCREW. THIS HAPPENED ON FOUR DIFFERENT OCCASIONS ON FOUR DIFFERENT PATIENTS. IT WAS INFORMED THAT THIS DID NOT CAUSE ANY HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE SURGEON WAS INSERTING THE SCREW MANUALLY WITH A HAND HELD HAND OPERATED SCREWDRIVER. THE BROKEN PIECE OF THE SCREW REMAINING IS IN THE POSSESSION OF THE HOSPITAL. THIS COMPLAINT CAPTURES PATIENT #2 (B)(4) IS RELATED TO THE FOLLOWING PCS THAT REPORT THE OTHER THREE OCCASIONS: (B)(4) - PATIENT #1, (B)(4) - PATIENT #3, (B)(4) - PATIENT #4. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TI MATRIXNEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    NO OTHER MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO DELAY IN SURGERY. THE SURGERY HAD A SUCCESSFUL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612434 TI MATRIXNEURO SCREW SELF-DRILLING 4MM PLATE, BONE JEY SYNTHES GMBH 04.503.104.01 928P411 10887587018324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown