BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK

    MDR report key: 8138439 · Received December 6, 2018

    Report

    Report Number
    8030965-2018-58803
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 16, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    UDI-DI
    07611819973916
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D10: THE DEVICE WAS RECEIVED. E1: STATE REPORTED AS (B)(6). H3, H4, H6: DEVICE HISTORY LOT, PART NUMBER: 04.503.740, LOT NUMBER: H090949, PART MANUFACTURE DATE: 02-MAY-2016, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: N/A. NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY: INVESTIGATION SITE: CQ ZUCHWIL, SELECTED FLOW: 5. BROKEN. VISUAL INSPECTION: THE MATRIXMANDIBLE RECONSTRUCTION PLATE IS BROKEN AS COMPLAINED. THE BREAKAGE OCCURRED IN TWO PLACES AND IN BETWEEN TWO PLATE HOLES. ON THE PLATE SURFACE THERE ARE SOME DENTS AND SCRATCHES VISIBLE, MOST PROBABLY FROM THE BENDING INSTRUMENTS. THE FRACTURE SURFACE IS TYPICAL FOR A FORCED FRACTURE. DIMENSIONAL INSPECTION: RELEVANT DIMENSION ¿THICKNESS OF TAB WAS CHECKED AND FOUND TO COMPLY WITH THE SPECIFICATIONS. DRAWING/SPECIFICATION REVIEWED/ MATERIAL REVIEW: THE CERTIFICATE OF THE RAW MATERIAL WAS REVIEWED DURING THE PERFORMED DEVICE HISTORY REVIEW; THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCES NOTED. THE MATRIXMANDIBLE RECONSTRUCTION PLATE IS MADE FROM PURE TITANIUM (TICP). SUMMARY' THE COMPLAINT CONDITION IS CONFIRMED AS THE MATRIXMANDIBLE RECONSTRUCTION PLATE IS BROKEN. THIS PRODUCTION LOT (H090949) WAS MANUFACTURED IN MAY 2016 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE GIVEN INFORMATION INDICATES THAT THE PLATE BROKE INTRA-OPERATIVE, MOST-PROBABLY DURING CONTOURING; AS NO MANUFACTURING RELATED DEFICIENCY WAS FOUND IT CAN BE CONCLUDED THAT THE PLATE BROKE DUE TO A MECHANICAL OVERLOADING. IMPORTANT NOTE: TITANIUM IMPLANTS SHOULD NEVER BE BENT FOR- AND BACKWARDS, NOTCHED, OR SCRATCHED. SUCH MANIPULATIONS CAN PRODUCE SURFACE DEFECTS AND/OR CONCENTRATE STRESS IN THE CORE OF THE IMPLANT. THIS IN TURN MAY EVENTUALLY CAUSE THE PRODUCT TO FAIL. 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. H11: D4: LOT NUMBER PROVIDED FOR REPORTING.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A MATRIX MANDIBLE RECONSTRUCTION PLATE ANGLE RIGHT WAS BROKEN. THE SURGEON USED ANOTHER PLATE WITH THE SAME TYPE TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A TITANIUM (TI) MATRIXMANDIBLE PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978305 TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK BONE PLATE JEY OBERDORF SYNTHES PRODUKTIONS GMBH H090949 07611819973916

    Patients

    Seq Age Sex Outcome Treatment
    1