BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 10644935 · Received October 7, 2020

    Report

    Report Number
    2939274-2020-04566
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 17, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. H10 ADDITIONAL NARRATIVE: D10: DEVICE RETURNED. D11: ADDITIONAL CONCOMITANT PRODUCT. H3, H4, H6: DEVICE HISTORY LOT. PART: 03.010.523. LOT: L811203. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: 07. SEPT. 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. H3, H6: INVESTIGATION SUMMARY: BACKGROUND: IT WAS REPORTED ON APRIL 01, 2020, A DRIVING CAP / THREADED WOULD NOT LONG THREAD INTO THE RADIOLUCENT INSERTION HANDLE. THE ISSUE WAS FOUND AT THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE DRIVING CAP / THREADED (PART#: 03.010.523, LOT: L811203 ) WAS RECEIVED AT US CQ. THE THREADED DISTAL TIP BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. THE DEVICE HAD SURFACE SCRATCHES ALONG THE SHAFT AND SEVERAL DENTS ON THE TOP OF THE PROXIMAL HEAD FROM HAMMER BLOWS. THESE COSMETIC ISSUES ARE CONSISTENT WITH NORMAL WEAR. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED. DIMENSIONAL INSPECTION: DUE TO THE BREAK BEING SLIGHTLY OBLIQUE IN NATURE AND IT ONLY LEAVING THE MOST PROXIMAL THREAD, IT WAS NOT POSSIBLE TO OBTAIN AN ACCURATE MEASUREMENT OF THE MINOR / MAJOR DIAMETER OF THE THREADED TIP. THE DIAMETER OF THE GROOVE JUST PROXIMAL TO THE BROKEN TIP AS WELL AS THE SHAFT DIAMETER WAS MEASURED INSTEAD. THE DRAWINGS WERE REVIEWED: CONCLUSION: THE MEASURING RESULT DOES SHOW CONFORMITY. DOCUMENT / SPECIFICATION REVIEW: THE FOLLOWING DRAWING, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WAS REVIEWED. CONNECTOR FOR INSERTION HANDLE SE_380067 REV L. 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 DRIVING CAP / THREADED (PART#: 03.010.523, LOT: L811203) AS THE THREADED DISTAL TIP WAS BROKEN OFF AT THE MOST PROXIMAL THREAD FORM, AND THEREFORE UNABLE TO THREAD AND ASSEMBLE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE (OFF-AXIS OR EXCESSIVE HAMMER BLOWS BASED ON THE NUMEROUS DENTS ON THE PROXIMAL SURFACE). 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, FURTHER INVESTIGATION WILL NOT BE CONDUCTED IN THIS COMPLAINT AS IT WILL BE ADDRESSED WITHIN. 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

    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 WHILE THE SURGEON WAS PERFORMING A FEMORAL RECON NAIL PROCEDURE, DURING INSERTION THE SURGEON USED A MALLET TO STRIKE THE DRIVING CAP/THREADED THAT WAS ATTACHED TO THE RADIOLUCENT INSERTION HANDLE. THE DRIVING CAP/THREADED BROKE OFF AT THE THREAD JUNCTION, LEAVING THE DRIVING CAP THREADS INSIDE THE INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE (PART# 03.033.001, LOT# L700505, QUANTITY 1), UNKNOWN MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 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
    1105182 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L811203 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP/THREADED.| RADIOLUCENT INSERTION HANDLE FRN.| RADIOLUCENT INSERTION HANDLE FRN.| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA.| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA.| UNK - NAILS: FEMORAL.