BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 8545654 · Received April 24, 2019

    Report

    Report Number
    2939274-2019-57620
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    March 29, 2019
    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
    PA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE DRIVING CAP/ THREADED (PART # 03.010.523, LOT # 9505723, MFG # 25-AUG-2015) WAS RECEIVED WITH THE DISTAL TIP OF THE DRIVING CAP BROKEN. THE BROKEN PORTION OF THE DEVICE WAS EMBEDDED IN THE RADIOLUCENT INSERTION HANDLE (PART# 03.010.486, LOT# 9102626) WHICH WAS RETURNED AS A CONCOMITANT DEVICE. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL ANALYSIS WAS NOT ABLE TO BE PERFORMED AS THE RELEVANT BROKEN PORTION WAS NOT ACCESSIBLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. THE COMPLAINT CONDITION IS CONFIRMED AS THE DRIVING CAP/ WAS RECEIVED WITH THE DISTAL TIP BROKEN. 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. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT; PART: 03.010.523; LOT: 9505723; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 25. AUG.2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. 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

    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 WHEN BACKSLAPPING THE DRIVING CAP OF THE RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM, THE THREADED PORTION OF THE DRIVING CAP BROKE OFF INSIDE OF THE INSERTION HANDLE ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100 MM (PART# 03.010.486, LOT# 9102626, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337223 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 9505723 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1