BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 10139846 · Received June 10, 2020

    Report

    Report Number
    2939274-2020-02760
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. H3, H6: PART: 03.010.523, LOT: 8953363, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 29. JULY 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE DRIVING CAP/THREADED (PART # 03.010.523 & LOT # L759640) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). THE VISUAL INSPECTION OF THE RECEIVED DEVICE INDICATED THAT THE THREADED DISTAL TIP WAS BROKEN OFF AT THE MOST PROXIMAL END. THE DEVICE HAD SEVERAL DENTS ON THE TOP OF THE PROXIMAL HEAD FROM HAMMER BLOWS. THESE COSMETIC ISSUES ARE CONSISTENT WITH NORMAL WEAR. THE BROKEN THREADED TIP PIECE WAS FOUND IN THE RECEIVED CONCOMITANT INSERTION HANDLE DEVICE (PART# 03.010.486, LOT# 9102626). DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. DUE TO THE THREADED DISTAL TIP WAS LODGED IN THE INSERTION HANDLE, THE DIAMETER OF THE GROOVE PROXIMAL TO THE BROKEN TIP WAS MEASURED. GROOVE DIAMETER: THIS WAS WITHIN THE SPECIFICATION. SHAFT DIAMETER ADJACENT TO THE BREAK THIS WAS WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS WERE REVIEWED. CONNECTOR FOR INSERTION HANDLE (MANUFACTURED) & (CURRENT) DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE RECEIVED DEVICE AS THE THREADED DISTAL TIP WAS BROKEN OFF AT THE MOST PROXIMAL THREAD PART. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES WHEN USED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. THE NEED FOR FURTHER CORRECTIVE/PREVENTIVE ACTION WILL BE ASSESSED WITHIN THE PIE. FURTHER INVESTIGATION WILL NOT BE CONDUCTED IN THIS COMPLAINT AS IT WILL BE ADDRESSED WITHIN THE PIE. SUSTAINING ENGINEERING TICKET HAS ALSO BEEN OPENED TO ADDRESS THIS ISSUE. 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 · 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. H3, H6: 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 · 0

    CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM (PART NUMBER 03.010.486, LOT 9102626, QUANTITY# 1), IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), IMPACTION INSTRUMENTS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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 ON (B)(6) 2020, DURING THE CASE WHEN THE SURGEON WAS INSERTING A RA FEMORAL NAIL, THE DRIVING CAP BROKE INSIDE THE INSERTION HANDLE. THE DRIVING CAP DID NOT BREAK IN THE PATIENT. FRAGMENTS WERE EASILY REMOVED WITHOUT ANY MEDICAL INTERVENTION. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM (PART NUMBER 03.010.486, LOT 9102626, QUANTITY# 1), IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), IMPACTION INSTRUMENTS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603902 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 8953363 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 RADIOLUCENT INSERTION HANDLE| RADIOLUCENT INSERTION HANDLE| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - IMPACTION INSTRUMENTS: TRAUMA| UNK - IMPACTION INSTRUMENTS: TRAUMA| UNK - NAILS