BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPT F/SELDRILL SCHANZ SCR Ø5

    MDR report key: 20171649 · Received September 9, 2024

    Report

    Report Number
    8030965-2024-11006
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 15, 2024
    Report Date
    September 9, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFC
    UDI-DI
    07611819775770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED SIGNS OF NORMAL USE. NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. IN ADDITION, THE DEVICE REMAINS ASSEMBLED WITH THE MATING DEVICE 5.0 SELF-DRILLING SCHANZ SCR 80 THRD/200 (294.786). A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL EVALUATION WAS PERFORMED SEVERAL ATTEMPTS OF DISASSEMBLY WERE MADE. IT WAS NOT POSSIBLE TO SEPARATE BOTH DEVICES. THEREFORE, THE CUSTOMER'S ALLEGATION CAN BE CONFIRMED. WITH THE INFORMATION RECEIVED AND AFTER THE INVESTIGATION IT WAS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE FOR THE ISSUE EXPERIMENTED BY THE CUSTOMER. SINCE THE DEVICE WAS UNABLE TO BE DISASSEMBLED, IT WAS NOT POSSIBLE TO SEE ANY DAMAGE THAT COULD CAUSE THE MALFUNCTION OF THE DEVICE. ONCE THE PRODUCT LEAVES J&J MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT CONDITIONS THE DEVICE IS EXPOSED TO. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ADAPT F/SELDRILL SCHANZ SCR Ø5 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): PART # 393.103; SYNTHES LOT # FT00060; SUPPLIER LOT# FT00060; RELEASE TO WAREHOUSE DATE: 15 JULY 2016. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS 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 · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 WHILE PUTTING ON A SYNTHES LG EXTERNAL FIXATOR. THE SURGEON WAS USING A SELF DRILLING SCHANZ SCREW CATALOG #294.786 ON THE TIBIA. THE SCHANZ SCREW WAS BEING INSERTED USING THE POWER ADAPTOR 393.103 FROM THE LG EX-FIX TRAY. THE SURGEON HAD PREDRILLED THE HOLE WITH A3.5 DRILL. THE PIN HIT THE FAR CORTEX AND STOPPED THE DRILL. THE PIN BECAME STUCK IN THE POWER ADAPTOR AND COULD NOT BE REMOVED. WE HAD TO CUT THE PIN WITH THE ADAPTOR IN ORDER TO CONTINUE WITH THE CASE. THERE WAS A 30 MINUTES OF SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563709 ADAPT F/SELDRILL SCHANZ SCR Ø5 DRIVER, SURGICAL, PIN GFC SYNTHES GMBH FT00060 07611819775770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male 5.0 SELF-DRILLING SCHANZ SCR 80 THRD/200