BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES

    MDR report key: 18293408 · Received December 8, 2023

    Report

    Report Number
    8030965-2023-15528
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    October 12, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    UDI-DI
    10886982075475
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H6: PART 03.130.271 LOT: T121577 MANUFACTURING SITE: TUTTLINGEN RELEASE TO WAREHOUSE DATE: 19 NOVEMBER 2015 A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CUTTING JAW LOWER IS BENT CAUSING TO NOT CUT CORRECTLY , THE DEVICE SHOWS SIGNS OF USE IN THE CUTTING JAWS LOWER AND UPPER HOWEVER WITHOUT THE MATING DEVICE A FUNCTIONAL TEST CANNOT BE PERFORMED. NO OTHER FINDING IS SEEN. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PLATE CUTTER FOR 1.3/1.5 AND 2.0 PLATES CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED THE SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. 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 · 0

    IT WAS REPORTED THAT ON OCTOBER 12, 2023, A PLATE CUTTER AND AN NAIL EXTRACTOR WERE DULL AND WOULD NOT CUT. UPON MANUFACTURER INSPECTION, IT WAS DETERMINED THAT THE PLATE CUTTER LOWER JAW WAS BENT, CAUSING IT TO NOT CUT CORRECTLY. THIS REPORT IS FOR A PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272073 PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES INSTRUMENT, CUTTING, ORTHOPEDIC HTZ SYNTHES GMBH T121577 10886982075475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NAIL EXTRACTOR