BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/LEFT/2.5MM THK

    MDR report key: 6303424 · Received February 6, 2017

    Report

    Report Number
    1000562954-2017-10007
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JEY
    UDI-DI
    07611819363298
    PMA / PMN Number
    K113251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE PLATE SHOWS MULTIPLE INDENTATIONS ALL ALONG THE PLATE. THE PREFORMED SECTION OF THE PLATE HAS BEEN UN-BENT TO A STRAIGHT SHAPE. THE HOLES HAVE BEEN CUT FROM BOTH ENDS OF THE PLATE. THE PLATE SHOWS EVIDENCE OF MISUSE (NON-BENDABLE SECTION WAS BENT) AND EVIDENCE OF REVERSE BENDING AT THE FRACTURE POINT. DESIGN RELATED ROOT CAUSE IS EXCLUDED. THE COMPLAINT IS INVALID. 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

    A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/LEFT/2.5MM THK, PART NUMBER 04.503.901, LOT NUMBER L085564). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING PART RECEIVED IN A MINIGRIP. THE PLATE IS BROKEN IN 4 PIECES. THE SURFACE IS SERIOUSLY DAMAGED. THE NUMBERS ETCHED ON THE PART MATCH WITH THE DATA REPORTED IN THE SYSTEM. DHR REVIEW LOT#L085564 HAS BEEN MANUFACTURED STARTING FROM THE SEMIFINISHED PRODUCT LOT#L057804 WHICH IS OBTAINED STARTING FROM SEMIFINISHED LOT#9901120 PRODUCED WITH RAW MATERIAL LOT#19164. THE DHRS OF THE SEMIFINISHED PRODUCTS AND OF THE TOP LEVEL HAVE BEEN REVIEWED AND NO NCRS WERE GENERATED DURING PRODUCTION, NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION FOUND. THE CERTIFICATE OF THE RAW MATERIAL LOT#19164 WAS REVIEWED, NO ANOMALY FOUND, THE MATERIAL WAS CONFORMING TO SPECIFICATION. PRODUCT INSPECTION THE PLATE BROKE IN THE AREA BETWEEN THE HOLES, WHERE THE PLATE IS USUALLY CUTTED TO ADJUST THE PLATE LENGTH AS PER SURGICAL TECHNIQUE. THE MAIN FEATURES OF THIS AREA WERE MEASURED CLOSED TO THE FRACTURE, ALL THE FEATURES WERE FOUND WITHIN SPECIFICATIONS. FROM VISUAL INSPECTION IT IS EVIDENT THAT THE PLATE SURFACE IS SERIOUSLY DAMAGED POST PRODUCTION. CONCLUSION CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEM, THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE RETURNED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. COMPLAINT IS DISPOSED AS CONFIRMED DUE TO EVIDENCE THAT PART IS BROKEN, BUT IT'S CONSIDERED NOT VALID FOR (B)(4) BECAUSE THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    COMPLAINT OCCURRED PRIOR TO THE SURGERY; THERE WAS NO PATIENT INVOLVEMENT. DEVICE WAS NOT IMPLANTED/EXPLANTED. PHONE NUMBER: (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: AUGUST 08, 2016. 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 THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE THE SURGEON WAS PREFORMING A PRE-MOLD OF THE PATIENT¿S PLATE PRIOR TO SURGERY, THE PLATE BROKE AT THE TIME OF THE DOUBLING WITH THE INSTRUMENTS. IT WAS NOTED THAT THE SIDE WHERE THE PLATE WAS SPLIT HAD NOT BEEN PREVIOUSLY MANIPULATED. CONCOMITANT PART: UNKNOWN INSTRUMENTS (PART UNKNOWN / LOT UNKNOWN / QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87939 TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/LEFT/2.5MM THK BONE PLATE JEY SYNTHES MEZZOVICO L085564 07611819363298

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN QUANTITY OF UNKNOWN INSTRUMENTS