BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMPING FOOT FOR 328.040 LCP 3.5MM AND LC-DCP 3.5MM

    MDR report key: 9844801 · Received March 17, 2020

    Report

    Report Number
    2939274-2020-01313
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 19, 2020
    Report Date
    February 19, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982191359
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY INVESTIGATION FLOW: DAMAGE VISUAL INSPECTION: THE CLAMPING FOOT FOR 328.040 LCP® 3.5MM AND LC-DCP® 3.5MM (P/N: 325.041, LOT NUMBER: 3150713) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, ONE OF THE RETAINING JAWS HAS BROKEN OFF. DEVICE FAILURE/DEFECT IDENTIFIED? YES DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS ONE OF THE RETAINING JAWS HAS BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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, IT HAS BEEN DETERMINED THAT 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: 325.041 LOT: 3150713 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: JUN. 18, 2009 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    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 FEBRUARY 19, 2020, THE CLAMPING FOOT BROKE DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMUR. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308124 CLAMPING FOOT FOR 328.040 LCP 3.5MM AND LC-DCP 3.5MM GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 325.041 3150713 10886982191359

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR CLMPNG FT FR 328.040 LCP 3.5MM N LC-DCP 3.5MM