BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATMATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM

    MDR report key: 5584579 · Received April 18, 2016

    Report

    Report Number
    1719045-2016-10331
    Event Type
    Malfunction
    Date Received
    April 18, 2016
    Date of Event
    March 22, 2016
    Report Date
    March 23, 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

    PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING FIVE (5) SCREWDRIVERS WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT/WILL NOT FUNCTION: WILL NOT HOLD.¿ ONE (1) MATRIXMIDFACE SCREWDRIVER BLADE, HEX COUPLING, SELF-RETAINING, 76MM (PART NUMBER 03.503.202, LOT NUMBER U200776). ONE (1) MATRIXNEURO SCREWDRIVER BLADE, HEX COUPLING, SELF-RETAINING, MEDIUM (PART NUMBER 03.503.017, LOT NUMBER U112147). THREE (3) MATRIXMIDFACE SCREWDRIVER BLADE, HEX COUPLING, SELF-RETAINING, 96MM (PART NUMBER 03.503.203, LOT NUMBER U186307). THE COMPLAINT CONDITION IS UNCONFIRMED AS THE ISSUE COULD NOT BE REPLICATED. THE DEVICES WERE TESTED FUNCTIONALLY WITH A 1.85MM TITANIUM MATRIX SCREW, SELF-DRILLING AND A TITANIUM MATRIXNEURO SCREW, SELF-DRILLING. AT NO TIME DURING TESTING DID THE SCREWDRIVERS FAIL TO RETAIN THEIR RESPECTIVE INTENDED SCREWS. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE INVESTIGATION SHOWS THAT PART FAMILY 03.503.20X COMES IN THREE LENGTHS [52MM, 76MM, AND 96MM] AND IS PART OF THE MATRIXMIDFACE AND MATRIXORTHOGNATHIC SYSTEMS. PART FAMILY 03.503.01X COMES IN TWO LENGTHS [SHORT AND MEDIUM] AND IS PART OF THE MATRIXNEURO SYSTEM. THESE SCREWDRIVERS ARE INTENDED RETAIN THE SCREW WITHOUT A HOLDING SLEEVE DURING USE. THIS INFORMATION IS PROVIDED PER THE MATRIXORTHOGNATHIC PLATING SYSTEM TECHNIQUE GUIDE, THE NEXT GENERATION CRANIAL PLATING SYSTEM: MATRIXNEURO TECHNIQUE GUIDE, AND THE MATRIXMIDFACE PLATING SYSTEM. THE SCREWDRIVERS WERE RECEIVED INTACT WITH LIGHT WEAR. ON EACH SCREWDRIVER, THE PROXIMAL COUPLING HEX AND THE DISTAL CRUCIFORM BLADE SHOW SLIGHTLY WORN EDGES. A REVIEW OF THE CURRENT DESIGN DRAWING/MANUFACTURED REVISION FOR THE MATRIXMIDFACE/MATRIXORTHOGNATHIC SCREWDRIVERS AND THE MATRIXNEURO SCREWDRIVER WAS PERFORMED. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. IN CONCLUSION, THE DEVICES WERE FOUND TO BE IN GOOD FUNCTIONING CONDITION AND DID NOT EXHIBIT ANY UNSPECIFIED FUNCTIONAL ISSUES. AS THERE WERE NO ISSUES IDENTIFIED WITH THE RETURNED DEVICES, A RISK ASSESSMENT REVIEW IS NOT APPLICABLE. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PATIENT INFORMATION IS UNKNOWN DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PHONE NUMBER: (B)(6). PART NUMBER: 03.503.203, LOT NUMBER: U186307: RELEASE TO WAREHOUSE DATE: APRIL 21, 2014. MANUFACTURING SITE IS (B)(4) AND SUPPLIED BY (B)(4). 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 THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE SCREWDRIVER BLADES DO NOT HOLD THE SCREWS PROPERLY. THIS OCCURRED DURING AN INITIAL MAXILLO FACIAL PROCEDURE; OTHER PARTS WERE AVAILABLE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239992 MATMATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM SCREWDRIVERS HXX SYNTHES MONUMENT U186307

    Patients

    Seq Age Sex Outcome Treatment
    1