BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE FOR CABLE CUTTER

    MDR report key: 11135317 · Received January 7, 2021

    Report

    Report Number
    2939274-2021-00091
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 10, 2020
    Report Date
    December 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    UDI-DI
    10886982076717
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6- BLADE FOR CABLE CUTTER (PART: 03.221.008, LOT: T162927) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE LOOKS GOOD WITHOUT ANY VISUAL DAMAGE. NO DEFECTS WERE IDENTIFIED ON DEVICE. THE COMPLAINT CANNOT BE CONFIRMED FOR BLADE FOR CABLE CUTTER (PART: 03.221.008, LOT: T162927) AS NO VISUAL DAMAGE WAS EVIDENT WITH THE RETURNED DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PROBLEM. 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 NUMBER: 03.221.006; LOT NUMBER: T162927; MANUFACTURING SITE: TUTTLINGEN; RELEASE TO WAREHOUSE DATE: 09-NOV-2018. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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. B5

    Description of Event or Problem · 0

    THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J SALES REPRESENTATIVE. 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 ON (B)(6) 2020, DURING AN ORTHOPEDIC PROCEDURE OF THE PROXIMAL FEMUR A COLLINEAR CLAMP AND AN IMPACTOR HAD AN UNKNOWN ALLEGATION ALONG WITH THE TWO (2) BROKEN CUTTER. THERE WAS NO SURGICAL DELAY. A DIFFERENT SET WAS USED. THERE WERE NO FRAGMENTS GENERATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM. THIS REPORT IS FOR ONE (1) BLADE FOR CABLE CUTTER THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27226 BLADE FOR CABLE CUTTER CUTTER,WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.221.008 T162927 10886982076717

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR