BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 9545893 · Received January 3, 2020

    Report

    Report Number
    2939274-2020-00033
    Event Type
    Injury
    Date Received
    January 3, 2020
    Report Date
    December 9, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194114
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. H10 ADDITIONAL NARRATIVE: D4 LOT. D10. G1 MFG. H3, H4, H6 INVESTIGATION SUMMARY. VISUAL INSPECTION: THE 5.0MM FLEXIBLE SHAFT WAS RECEIVED AT US CQ. THE DEVICE SHAFT BROKE JUST PROXIMAL OF THE HEX COUPLING COMPONENT. THE FRAGMENT WAS RETURNED AS THE COMPLETE ASSEMBLY WAS PRESENT. THERE WERE NO OTHER DEFECTS IDENTIFIED WITH THE DEVICE. THE OVERALL COMPLAINT WAS CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED? YES; SHAFT BROKE BY THE COUPLING. DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS: SHAFT DIAMETER = 5.08 +/- 0.0254MM. MEASURED DIMENSIONS: SHAFT DIAMETER = 5.078MM; CONFORMING. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS) NO ISSUES. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED 5.0MM FLEXIBLE SHAFT AS THE DEVICE BROKE JUST PROXIMAL OF THE COUPLING. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED IT'S POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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. DEVICE HISTORY PART: 352.040. SYNTHES LOT: 4767722. SUPPLIER LOT: 2090792. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: (B)(6) 2004. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS COMPANY REPRESENTATIVE. (B)(4). 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 · 1

    IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAIL OF THE TIBIA SURGERY ON AN UNKNOWN DATE, THE (2) FLEXIBLE SHAFTS BROKE WHEN THE SURGEON WAS REAMING THE TIBIA CANAL WITH AN UNKNOWN STRYKER SYSTEM 8 DRILL. DURING THE REAMING PROCESS, THE REAMER SHAFT BROKE IN HALF AND AFTER THAT, A SECOND REAMER WAS USED AND IT BROKE INTO 3 PIECES. THE SURGEON MADE A SMALL INCISION AND USED LONG CLAMPS TO ASSIST IN THE REMOVAL OF THE BROKEN FRAGMENTS. THERE WAS A SURGICAL DELAY OF 20 MINUTES. ALL FRAGMENTS WERE REMOVED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT USE OF ANY ADDITIONAL REAMER. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN STRYKER SYSTEM 8 DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN REAMER HEAD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR 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
    11200 5.0MM FLEXIBLE SHAFT REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.040 2090792 10886982194114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - REAMERS: REAMER HEAD.| UNKNOWN STRYKER SYSTEM 8 DRILL.