BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE PREFORMED RECON PL/MED/RIGHT/2.5MM THK

    MDR report key: 6142546 · Received December 2, 2016

    Report

    Report Number
    1000562954-2016-10223
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JEY
    PMA / PMN Number
    K113251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT PART & DEVICE LOT. PART # 04.503.902, LOT 9214011; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 22 OCTOBER 2014; NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    REPORTER PHONE NUMBER: (B)(6). A MANUFACTURING INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE TI MATRIXMANDIBLE PREFORMED RECON PL/MED/RIGHT/2.5MM THK (PART # 04.503.902, LOT # 9214011). THE MATRIXMANDIBLE-PREFORMED-RECONSTRUCTION-PLATE IS BROKEN IN HALF AT A GROOVE BETWEEN TWO THREADED LOCKING BORES. AT BOTH SIDES OF THE FRACTURE THE PLATE SHOWS MARKS AND NICKS IN VARIOUS AREAS OF THE PLATE CAUSED FROM UNKNOWN INSTRUMENTS DURING PRE-BENDING. DIMENSION: BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS IN BROKEN AND/OR BENDED AREAS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE MEASURABLE DIMENSIONS OF INTACT AREAS WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE VALID TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. MATERIAL: THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD. CONCLUSION: THE PLATE SHOWS MARKS AND NICKS IN VARIOUS AREAS OF THE PLATE CAUSED FROM UNKNOWN INSTRUMENTS DURING PRE-BENDING. THE MANNER OF DAMAGE POINTS TO THE FACT THAT THE PLATE WAS NOT PRE-BENDED FOLLOWING AND USING THE SPECIAL INSTRUMENTS AS PER THE VALID SURGICAL TECHNIQUE FOR THE MATRIX MANDIBLE PREFORMED PLATES. PER TECHNIQUE GUIDE CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. IF THE SHAPE OF THE IMPLANT MUST BE ALTERED, THE DEVICE SHOULD NOT BE BENT SHARPLY, BENT BACKWARDS, NOTCHED, OR SCRATCHED. SUCH MANIPULATIONS, IN ADDITION TO ALL OTHER IMPROPER HANDLING OR USE, CAN PRODUCE SURFACE DEFECTS AND/OR CONCENTRATE STRESS IN THE CORE OF THE IMPLANT. THIS IN TURN MAY EVENTUALLY CAUSE THE PRODUCT TO FAIL. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHAT INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. THIS COMPLAINT WAS DETERMINED TO BE CAUSED DURING A MECHANICAL OVERLOADING SITUATION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ACCORDING TO SURGEON THEY TRIED TO BEND THE PLATE WITH THE 3D BENDING PLIER, I BENT ONCE TO MAKE IT MORE CURVED, AND THEN SLIGHTLY BENT IT IN A REVERSE DIRECTION BUT IT BROKE. SURGEON HAD TO COMPROMISE TO USE THE LARGE SIZE WHICH IS SLIGHTLY BIGGER FOR THE PATIENT. THE IMPLANT IS NEWLY OPENED FROM THE PACKAGE TO BE REFILLED IN THE SET. NO DELAY TO SURGERY REPORTED. NO PATENT HARM REPORTED. THE DEVICE WAS BROKEN BEFORE IMPLANTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY: A LARGE SIZE IMPLANT IS USED STEAD OF THE M SIZE AND LESS FIT TO THE PATIENT. PROLONGATION OF THE SURGERY: APPROX. 20 MINUTES. NO FRAGMENTS REMAINED IN THE PATIENTS BODY. THIS COMPLAINT INVOLVES ONE PART. CONCOMITANT PART REPORTED: 1X UNKNOWN 3D BENDING PLIERS, PART UNK, LOT UNK. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE REPORTED ISSUE OCCURRED ON (B)(6) 2016 DURING INITIAL MANDIBLE RECONSTRUCTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792168 TI MATRIXMANDIBLE PREFORMED RECON PL/MED/RIGHT/2.5MM THK BONE PLATE JEY SYNTHES MEZZOVICO 9214011

    Patients

    Seq Age Sex Outcome Treatment
    1 1X UNKNOWN 3D BENDING PLIERS, PART UNK, LOT UNK