BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    MDR report key: 6411469 · Received March 16, 2017

    Report

    Report Number
    1719045-2017-10229
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    February 18, 2017
    Report Date
    February 20, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    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. ADDITIONAL DEVICE PRODUCT CODE IS DZL. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: DEC 8, 2016. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    ONE SCREW COULD BE REMOVED ENTIRELY IN TWO PIECES AND ONE SCREW COULD BE REMOVED ENTIRELY IN FRAGMENTS. THE THIRD SCREW COULD NOT BE REMOVED AND STILL REMAINS INTO PATIENT'S BODY BETWEEN THE PLATE AND THE BONE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017, THREE (3) MATRIX MIDFACE SCREWS BROKE DURING INSERTION. TWO (2) OF THE BROKEN SCREWS WERE ABLE TO BE REMOVED ENTIRELY; THE FIRST BROKE INTO TWO (2) PIECES, THE SECOND BROKE INTO SEVERAL FRAGMENTS. THE THIRD BROKEN SCREW BODY WAS RETAINED IN THE PATIENT BETWEEN THE PLATE AND THE PATIENT¿S BONE WITH THE TIP IN THE PATIENT¿S BONE. THE FRAGMENTS OF THE THIRD SCREW COULD NOT BE REMOVED. THE SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY AS THE SURGEON REDUCED AND STABILIZED THE FRACTURE. THE PATIENT¿S POSTOPERATIVE OUTCOME WAS STABLE. CONCOMITANT MEDICAL PRODUCTS: SCREW SELF-TAPPING (PART: 04.503.206.01C, LOT: H282478, QUANTITY: 12); SCREW SELF-DRILLING (PART: 04.503.226.01C, LOT: H261237, QUANTITY: 4); MATRIX MIDFACE ADAPTION PLATE: (PART: 04.503.376, LOT: H251265, QUANTITY: 1); DRILL BIT: (PART: 317.260, LOT: F-20360, QUANTITY: 1). THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192583 TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM BONE, PLATE JEY SYNTHES MONUMENT H251170

    Patients

    Seq Age Sex Outcome Treatment
    1 04.503.206.01C,TI MATRIXMIDFACE SCR 6MM, QTY 12| 04.503.226.01C, TI MATRIXMIDFACE SCR 6MM, QTY 4| 04.503.376, TI MATRIXMIDFACE ADAP PLATE/20 HOLES| 317.260, 1.1MM DRILL BIT/MINI QC WITH 6MM STOP