BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 6 HOLE PLATE 1.5MM THICK

    MDR report key: 10950281 · Received December 5, 2020

    Report

    Report Number
    8030965-2020-09410
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Report Date
    November 9, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    UDI-DI
    07611819974159
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H6: THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 04.503.715S, LOT: 8770579, MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 23 DEC 2013, EXPIRY DATE: 01 DEC 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED NON-STERILE PART WAS MANUFACTURED IN ELMIRA. PART NUMBER: 04.503.715, LOT NUMBER: 7536910, PART MANUFACTURE DATE: 15-NOV-2013, 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 6 HOLE PLATE 1.5MM 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. 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. PRODUCT WAS NOT RETURNED AND THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE. THIS COMPLAINT WILL BE RATED AS CONFIRMED AS THE INVESTIGATION HAS SHOWN THAT THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION. 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. 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. 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

    INITIAL REPORTER IS A SYNTHES SALES REPRESENTATIVE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2020, A REMOVAL PROCEDURE WAS PERFORMED TO REMOVE THE SCREWS. DURING THE SCREW REMOVAL, A THIN STRING-LIKE SILVER FOREIGN OBJECT WAS FOUND. THEY TRIED TO FIGURE OUT WHERE THE FOREIGN OBJECT CAME FROM BUT WERE NOT ABLE TO IDENTIFY IT. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2016. THIS REPORT IS FOR A MATRIX MANDIBLE PLATE. THIS IS REPORT 8 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416114 TI MATRIXMANDIBLE 6 HOLE PLATE 1.5MM THICK PLATE, BONE JEY SYNTHES GMBH 8770579 07611819974159

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP| LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP| LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP| LOCK SCR Ø2 SELF-TAP L14 TAN 1U I/CLIP| LOCK SCR Ø2 SELF-TAP L16 TAN 1U I/CLIP| LOCK SCR Ø2 SELF-TAP L6 TAN 1U I/CLIP| MATMAND SCR Ø2 SELF-TAP L5 TAN 1U I/CLIP| MATMAND SCR Ø2.4 SELF-TAP L6 TAN 1U I/CL| MATRIXMAND MINI-TENSIONPL NARROW CENTRE