BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 5MM

    MDR report key: 6800630 · Received August 17, 2017

    Report

    Report Number
    1719045-2017-10789
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 24, 2017
    Report Date
    July 25, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    UDI-DI
    07611819901667
    PMA / PMN Number
    K123723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODES: GWO, GXR. DEVICE BROKE DURING INSERTION; DEVICE NOT CONSIDERED IMPLANTED/EXPLANTED. (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART #: 04.503.105.01C, LOT#: H179571 (NON-STERILE) - TI MATRIXNEURO SCREW SELF- DRILLING 5 MM. QTY: 240: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 07-SEP-2016: INSPECTION SHEET- INSPECT DIMENSIONAL FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL PART 21015, LOT-9954218 RECEIVED FROM SUPPLIER (B)(4). PRODUCT (TITANIUM) CERTIFICATION TEST REPORT PROVIDED BY PERRYMAN MEETS SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. NO NON CONFORMANCE REPORTS (NCRS) 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 HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 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

    INVESTIGATION SUMMARY: THE INVESTIGATION HAS SHOWN, THAT BOTH SCREWS ARE BROKEN BETWEEN THE HEAD AND THE SHAFT. THE BROKEN OFF SCREW SHAFTS WERE NOT RETURNED AS IT REMAINED INSIDE THE SKULL. OTHERWISE THE SCREW HEADS ARE IN A GOOD CONDITION. THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THIS SCREW WAS MANUFACTURED IN SEPTEMBER 2016 ACCORDING TO THE SPECIFICATIONS. THE RELEVANT LENGTH CANNOT BE MEASURED DUE TO ITS BROKEN OFF CONDITION. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS BROKEN SCREW, BUT IT IS LIKELY THAT TOO MUCH APPLIED MECHANICAL FORCE CAUSED THIS DAMAGE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE AND FOLLOWING; ¿WARNINGS: THESE DEVICES CAN BREAK DURING USE (WHEN SUBJECTED TO EXCESSIVE FORCES OR OUTSIDE THE RECOMMENDED SURGICAL TECHNIQUE). NO PRODUCT RELATED ISSUES WERE IDENTIFIED. DEVICE 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 THAT ON (B)(6) 2017, THE SURGERY WAS PROCEEDING AS USUAL, WHEN BROCADE WAS PERFORMED. AFTER THE INSERTION OF THE SCREWS ON THE SKULL, THE SCREW HEADS BROKE AND THE BODY OF THE SCREWS REMAINED INSIDE PATIENT¿S SKULL. THIS HAPPENED WITH TWO (2) SCREWS DURING THIS SURGERY. THE SURGEON LEFT THE BODIES OF THE SCREWS INTO THE SKULL OF THE PATIENT AND CONTINUED WITH THE PLACEMENT OF THE OTHER PLATES. PATIENT STATUS REPORTED AS STABLE. NO PATIENT HARM REPORTED. SURGERY WAS PROLONGED FOR 5-10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: PLATE, SCREWS. THIS REPORT IS FOR ONE (1) TI MATRIXNEURO SCREW SELF-DRILLING 5 MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE SURGEON LEFT THE BODIES OF THE SCREWS INTO THE SKULL OF THE PATIENT AND CONTINUED WITH THE PLACEMENT OF THE OTHER SCREWS. CONCOMITANT: MATRIXNEURO CRANIAL PLATE, (PART# 04.503.062 / LOT# UNKNOWN / QUANTITY 3). MATRIXNEURO CRANIAL PLATE, (PART# 04.503.063 / LOT# UNKNOWN / QUANTITY 5). SCREWS (PART# 04.503.103.01C / LOT# UNKNOWN / QUANTITY 2). SCREWS (PART# 04.503.104.01C / LOT# UNKNOWN / QUANTITY 18).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581917 TI MATRIXNEURO SCREW SELF-DRILLING 5MM BONE, PLATE JEY SYNTHES MONUMENT H179571 07611819901667

    Patients

    Seq Age Sex Outcome Treatment
    1