BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 18987466 · Received March 27, 2024

    Report

    Report Number
    8030965-2024-04153
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    February 23, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SHAFT OF THE SYNREAM FLEXSHAFT WAS BROKEN. FRAGMENT WAS RECEIVED FOR EVALUATION. NO OTHER ISSUES WERE IDENTIFIED. A DIMENSIONAL INSPECTION FOR THE SYNREAM FLEXSHAFT WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. 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 SYNREAM FLEXSHAFT WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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 REVIEWED DIMENSIONAL INSPECTION: N/A DEVICE HISTORY LOT PART:352.040 LOT:8972023 MANUFACTURING SITE: WERK BETTLACH SUPPLIER: NA RELEASE TO WAREHOUSE DATE:20 JUN 2014 EXPIRATION DATE: NA A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE.

    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. D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. D10 THERAPY DATE: (B)(6), 2024. E1 INITIAL REPORT PHONE NUMBER: (B)(6). H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE SYNREAM SHAFT BROKE AND THE DRILL HEAD REMAINED IN THE MEDULLARY CANAL. THE PATIENT HAS HISTOLOGICALLY CONFIRMED BREAST CANCER WITH MULTIPLE OSSEOUS METASTASES. THE RIGHT FEMUR WAS MARKEDLY OSTEOLYTIC WITH A CONSIDERABLE RISK OF FRACTURE. ON THE OPPOSITE SIDE ON THE LEFT MULTIPLE METASTASES WITH RISK OF FRACTURE. HOWEVER, THE BONE SUBSTANCE WAS STILL SUFFICIENT HERE, SO THERE WAS INDICATION FOR NAILLESS OSTEOSYNTHESIS. ENTRY INTO THE OPERATING ROOM, LATERAL POSITION, SURGICAL DISINFECTION AND STERILE DISINFECTION OF THE OPERATING FIELD. STARTED WITH THE LEFT SIDE FOR NAIL IMPLANTATION. PRESENTATION WAS UNDER VISUALIZATION CONTROL. OPENING OF THE MEDULLARY CANAL, INSERTION OF AN INTRAMEDULLARY WIRE WAS PERFORMED. CONTROL IN 2 PLANES. THEN REAMING OF THE MEDULLARY CANAL WAS CONDUCTED. DURING REAMING AT 12 MM, THE SYNREAM SHAFT BROKE OFF AND THE DRILL HEAD REMAINED IN THE MEDULLARY CANAL. ACCORDINGLY, THE MEDULLARY CANAL NEEDED TO BE OPENED THROUGH THE KNEE AND THE REAMER RETRIEVED, AS IT COULD NO LONGER BE PULLED OUT USING THE WIRE. THE SURGICAL TEAM HAD TO DRILL OVER THE REAMER, THEN KNOCK IT OUT WITH THE NAIL INSERTED ANTEGRADE AND THEN RECOVERED THE DISTAL DRILL HEAD. THEY THEN PLACED THE NAIL IN ITS FINAL POSITION AND INSERTED THE FEMORAL LAG SCREW IN THE CENTER/CENTER POSITION. TO DO THIS, THE FEMORAL NECK WIRE NEEDED TO BE PLACED FIRST. THEY DRILLED OVER OF THE FEMORAL NECK WIRE AND INSERTED THE NAIL. STATIC LOCKING PROXIMALLY WAS PERFORMED. THEY THEN DRILLED THE DISTAL LOCKING UNDER BV. INSERTED THE CORRESPONDING SCREW UNDER BV, THEN IRRIGATION OF THE SITUS BOTH PROXIMALLY AND DISTALLY WAS PERFORMED. LAYERED PROXIMAL AS WELL AS DISTAL. LAYERED WOUND CLOSURE OF ALL ACCESS POINTS. STERILE DRESSING WAS CONDUCTED. THE SURGERY AND ANESTHESIA TIME WAS PROLONGED BY THE INCIDENT, AND AN ADDITIONAL SURGICAL ACCESS WAS REQUIRED. THIS REPORT INVOLVES ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985235 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES GMBH 8972023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SYNREAM REAMER HEAD Ø12| UNK - CABLE/WIRE| UNK - NAILS| UNK - SCREWS: LAG