BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 8375203 · Received February 27, 2019

    Report

    Report Number
    2939274-2019-56706
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 2, 2019
    Report Date
    February 2, 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
    GA, 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. BROKEN FLOW: VISUAL INSPECTION: UPON VISUAL INSPECTION, THE COMPLAINT CONDITION WAS CONFIRMED, AS THE DEVICE HAS BROKEN AT THE MOST PROXIMAL THREAD FORM OF THE DISTAL THREADED TIP AND THE BROKEN TIP WAS RETURNED. DIMENSIONAL INSPECTION: ACCURATE DIMENSION ANALYSIS TO MEASURE THE RETURNED BROKEN THREADED PORTION OF DISTAL TIP COULD NOT PERFORMED DUE TO THE FRACTION PATTERN / OBLIQUE THREADS. DHR AND RAW MATERIAL REVIEW: 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. INVESTIGATION CONCLUSION: THE EXACT CAUSE OF THE BREAKAGE IS UNKNOWN. IT IS POSSIBLE THAT AN OFF-AXIS STRIKE ON THE DRIVING CAP CONTRIBUTED TO THE COMPLAINT CONDITION. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, 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 HISTORY LOT: PART: 03.010.523, LOT: L811199, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 08. JUNE 2018. 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 A SYNTHES EMPLOYEE. THE DEVICE WAS 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 ON (B)(6) 2019, THE THREADED DRIVING CAP BROKE OFF IN THE INSERTION HANDLE DURING PLACEMENT OF A FEMORAL RECON NAIL (FRN). THE INSERTION HANDLE WAS REMOVED AND REPLACED WITH A NEW INSERTION HANDLE AND DRIVING CAP. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED; NONE REMAINED AS VERIFIED BY X-RAY. THERE WAS AN ADDITIONAL ANTIBIOTIC DOSAGE ADMINISTERED DUE TO OPERATIVE TIME.THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FORTY-FIVE (45) MINUTE DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: FEMORAL RECON NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1 ), INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1).THIS REPORT IS FOR A DRIVING CAP/THREADED.THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168612 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L811199 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR