BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 8502008 · Received April 10, 2019

    Report

    Report Number
    2939274-2019-57430
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 20, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982196064
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 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 · 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. PART 357.372, LOT 6242874: RELEASE TO WAREHOUSE DATE: OCTOBER 15, 2009. MANUFACTURING SITE: SYNTHES BRANDYWINE. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE HELICAL INSERTER HANDLE IS DAMAGED AND THE REPLACEMENT ALIGNMENT IS BROKEN AT THE SCREW. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE HELICAL BLADE INSERTER WAS RECEIVED DISSEMBLED. THE GUIDE SHAFT AND THE HAND GRIP ARE ATTACHED TOGETHER. THE SHAFT IS WORN ALONG ITS LENGTH WITH A PATCH OF SMALL DENTS CLOSE TO THE GRIP. THE HAND GRIP IS ABLE TO BE REMOVED AND IS COVERED IN SMALL DENTS AND SCRATCHES. THE ALIGNMENT INDICATOR IS DETACHED FROM THE MAIN ASSEMBLY. THE ALIGNMENT INDICATOR IS SCRATCHED AND DENTED. THE LOCKING SHAFT SUBCOMPONENT OF THE ALIGNMENT INDICATOR IS BROKEN, WITH PART OF IT LODGED IN THE ALIGNMENT INDICATOR, AND THE REST IS MISSING. THE BREAKAGE CONFIRMS THE COMPLAINT. THERE IS NO ISSUE IN REASSEMBLING THE DEVICE. THE RELEVANT DRAWINGS WERE REVIEWED. THE COMPLAINT IS CONFIRMED AS THE DEVICE WAS RECEIVED WITH THE ALIGNMENT INDICATOR HAVING A BROKEN LOCKING SHAFT SUBCOMPONENT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. 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 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

    OCCUPATION: REPORTER IS SYNTHES SALES CONSULTANT. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, THE HELICAL BLADE INSERTER WAS BROKEN. IT DID NOT CAUSE ANY HARM TO THE PATIENT BUT THE INSTRUMENT IS NOT USEFUL RIGHT NOW. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292335 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.372 6242874 10886982196064

    Patients

    Seq Age Sex Outcome Treatment
    1