BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM

    MDR report key: 9714420 · Received February 14, 2020

    Report

    Report Number
    2939274-2020-00857
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Report Date
    January 24, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXB
    UDI-DI
    10886982069696
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. INVESTIGATION SUMMARY. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM (P/N: 03.019.029, LOT NUMBER: 8802736) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE MIDDLE OF THE SHAFT IS BENT. THE TIP IS NOT BROKEN OFF, THERE IS NO HOOK PER THE DRAWING. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THE DEVICE SHAFT IS BENT BUT THE TIP IS NOT BROKEN. 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: 03.019.029, LOT: 8802736, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: MAY 27, 2014. 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

    REPORTER IS SYNTHES EMPLOYEE. 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 DURING RESTOCKING AND INSPECTION OF THE INSTRUMENT SET AT THE METRO OFFICE ON (B)(6) 2020, THE TIP OF THE DEPTH PROBE FOR HUMERAL NAILING SYSTEM WAS DISCOVERED BROKEN OFF. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176662 DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM PROBE HXB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.019.029 8802736 10886982069696

    Patients

    Seq Age Sex Outcome Treatment
    1