BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76MM

    MDR report key: 5720593 · Received June 13, 2016

    Report

    Report Number
    1719045-2016-10488
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 27, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. PRODUCT INVESTIGATION SUMMARY: ONE (1) MATRIXMIDFACE SCREWDRIVER BLADE (PART: 03.503.202 / LOT: U200776) WAS RECEIVED FOR EVALUATION. THE COMPLAINT CONDITION IS CONFIRMED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE MATRIXMIDFACE SCREWDRIVER BLADE IS NOTED IN THREE TECHNIQUE GUIDES: MATRIXORTHOGNATHIC, ORTHODONTIC BOND ANCHOR, AND MATRIXCOMBO PLATING. IN EACH SYSTEM, THE DRIVER IS AVAILABLE FOR SCREW INSERTION. THE RETURNED DRIVER WAS EXAMINED UNDER MAGNIFICATION AND THE DRIVE TIP WAS FOUND TO SHOW MINOR WEAR CONSISTENT WITH REPEATED USE OVER 2+ YEARS IN THE FIELD. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. A REVIEW OF THE CURRENT DESIGN DRAWING AND AVAILABLE HISTORY FOR THE TOP LEVEL DRAWING FOR THE SCREWDRIVER WAS PERFORMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, THE DRIVER TIPS ARE WORN, WHICH IS CONSISTENT WITH 2+ YEARS OF USE. ADDITIONALLY, WORN DRIVE RECESSES FOR THE SCREWS WOULD POTENTIALLY CONTRIBUTE TO THE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. REPORTING FACILITY STREET ADDRESS CORRECTED. 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

    (B)(6) REPORTED THAT ON (B)(6) 2016 DURING AN ORTHOGNATHIC CASE, A MATRIXMIDFACE SCREWDRIVER DID NOT HOLD SCREWS PROPERLY. THE SURGERY WAS COMPLETED USING A LIKE DEVICE. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375945 MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76MM SCREWDRIVERS HXX SYNTHES MONUMENT U200776

    Patients

    Seq Age Sex Outcome Treatment
    1