BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 8091936 · Received November 20, 2018

    Report

    Report Number
    2939274-2018-55054
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Report Date
    December 21, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: B3: UNKNOWN DATE IN 2018. 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

    DEVICE HISTORY LOT PART: 03.010.475, LOT: L048481, MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 06.SEP.2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND MATERIAL HARDNESS CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY VISUAL INSPECTION: VISUAL INSPECTION PERFORMED OBSERVED THAT THE PARTIALLY-THREADED DISTAL TIP PORTION OF THE DRIVING CAP FRACTURED/BROKE AT ITS BASE. THE BROKEN PORTION WAS RETURNED. THE DEVICE SHOWS HAMMER MARKS ON THE TOP, THE SIDE AND UNDERSIDE OF THE HEAD. NO ADDITIONAL MALFUNCTIONS WERE IDENTIFIED. THE RECEIVED CONDITION AGREES WITH THE REPORTED CONDITION THEREFORE THE COMPLAINT IS CONFIRMED. THE DEVICE PROVIDES EVIDENCE OF INCORRECT USE OF THE DEVICE. BACKSLAPPING THE DEVICE WITHOUT USING PROPER TECHNIQUE WILL TRANSMIT OFF AXIS FORCES TO THE DEVICE AND CAN CAUSE THE BREAKAGE. AS THE CAUSE OF THE BROKEN DEVICE IS DETERMINED TO BE USE ERROR, FURTHER INVESTIGATION WILL NOT BE PERFORMED. THERE IS NO INDICATION OF DESIGN OR MANUFACTURING ISSUES WHICH CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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

    ADDITIONAL CONCOMITANT DEVICE: INSERTION HANDLE FOR SUPRAPATELLAR (PART 03.010.440, LOT 160187-101, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 0

    IT WAS NOTED THE EVENT OCCURRED ON AN UNKNOWN DATE IN 2018. THE THREADED END OF THE DRIVING CAP WAS STUCK IN THE INSERTION HANDLE; THE HOSPITAL WAS ABLE TO SUCCESSFULLY REMOVE THE DRIVING CAP SEGMENT FROM THE INSERTION HANDLE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 AN UNKNOWN DATE, DURING INSERTION OF EXPERT TIBIAL NAIL WITH SUPRAPATELLAR INSTRUMENTATION, THE DRIVING CAP BROKE AT THE JUNCTION OF THE THREADED END. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN EXPERT TIBIAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930643 DRIVING CAP MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC L048481

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR