BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7828306 · Received August 29, 2018

    Report

    Report Number
    2939274-2018-53530
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    June 11, 2018
    Report Date
    June 12, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587012513
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL ADDRESS IS UNKNOWN. PART: 03.503.202; SYNTHES LOT: U142727; SUPPLIER LOT: U142727; RELEASE TO WAREHOUSE DATE: NOVEMBER 10, 2011; MANUFACTURING SITE: SYNTHES (B)(4); SUPPLIER: (B)(4); NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) IDENTIFIED CUMULATIVE WEAR. THE DISTAL CRUCIFORM BLADE TIPS AND THE DISTAL SELF-RETAINING BOSS FEATURE SHOWED ROUNDED EDGES AND WEAR. IT WAS ALSO OBSERVED THAT THE WHITE EPOXY COLOR CODE RING HAS DISCOLORED/YELLOWED. FUNCTIONAL TEST: A FUNCTIONAL TEST TO REPLICATE THE REPORTED COMPLAINT CONDITION WAS NOT ABLE TO BE PERFORMED AT CQ BECAUSE THE SCREW INVOLVED IN THE EVENT WAS NOT RETURNED. THE REPORTED COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED AT CQ. ALTHOUGH THE REPORTED COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED AT CQ, THE CUMULATIVE WEAR ON THE DISTAL SELF-RETAINING FEATURES OF THE RETURNED DEVICE WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION. THEREFORE, THE RECEIVED CONDITION OF THE DEVICE IS CONSISTENT WITH THE REPORTED CONDITION AND THIS COMPLAINT IS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN NOVEMBER 2011 AND IS OVER 6 YEARS OLD. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. TABULATED PRODUCT DESIGN DRAWING FOR THE FAMILY OF MATRIXMIDFACE SELF-RETAINING CRUCIFORM BLADES WITH HEX COUPLING WAS REVIEWED DURING THIS INVESTIGATION. THE MATRIXMIDFACE SCREWDRIVER BLADE IS A REUSABLE INSTRUMENT NOTED IN THREE SYSTEMS: MATRIXORTHOGNATHIC, ORTHODONTIC BONE ANCHOR, AND MATRIXCOMBO PLATING. IN EACH SYSTEM THE DRIVER IS AVAILABLE FOR SCREW INSERTION. THE MATRIXORTHOGNATHIC SYSTEM CONTAINS THREE SCREWDRIVER BLADES WITH IDENTICAL DRIVE TIPS AND VARYING LENGTHS: 52 MM, 76 MM, AND 96 MM; THE DRIVERS ARE SELF-RETAINING. THE DESIGN HISTORY WAS NOT FOUND TO 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 PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DIMENSIONAL INSPECTION: AN ACCURATE RELEVANT DIMENSIONAL INSPECTION OF THE CRUCIFORM BLADES COULD NOT BE PERFORMED AT CQ BECAUSE OF THE POST MANUFACTURING WEAR. THE SHAFT DIAMETER JUST PROXIMAL TO THE DISTAL CRUCIFORM BLADE TIP MEASURED Ø2.65 MM AT CQ (CALIPERS CA592) WHICH IS WITHIN SPECIFICATION OF Ø2.6 MM +0.1/-0 MM PER TABULATED PRODUCT DESIGN DRAWING. A DIMENSIONAL INSPECTION RELEVANT TO THE DISCOLORED WHITE EPOXY RING WAS NOT ATTEMPTED DUE TO THE NATURE OF THE ISSUE. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT CONDITION AND THE EPOXY COLOR RING DISCOLORING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MOST LIKELY CAUSE IS CUMULATIVE WEAR FROM OVER 6 YEARS OF USE. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    IT WAS REPORTED THAT DURING TREATMENT OF A ZYGOMATIC BONE FRACTURE ON (B)(6) 2018, THE MATRIXMIDFACE SCREWDRIVER BLADE DID NOT HOLD THE MATRIXMIDFACE SCREW PROPERLY. PATIENT WAS BEING IMPLANTED WITH ONE (1) MATRIXMIDFACE ZYGOMA PLATE AND UNKNOWN QUANTITY OF 1.55 MM DIAMETER MITRIXMIDFACE SCREWS. ANOTHER SCREWDRIVER BLADE WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO SURGICAL DELAY NOTED. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICE: 1.55 MM MATRIXMIDFACE SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667736 MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.503.202 U142727 10887587012513

    Patients

    Seq Age Sex Outcome Treatment
    1