BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR

    MDR report key: 11219618 · Received January 22, 2021

    Report

    Report Number
    2939274-2021-00431
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Report Date
    December 29, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982068712
    PMA / PMN Number
    K111667
    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. PART NUMBER: 03.010.430, LOT NUMBER: T982288, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: DECEMBER 22, 2012. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR (P/N: 03.010.430, LOT NUMBER: T982288) WAS RECEIVED AT US CUSTOMER QUALITY CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE KNOB SHAFT WAS BENT. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE AND INACCESSIBILITY OF INTERNAL COMPONENTS. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE KNOB SHAFT IS BENT WHICH COULD RENDER THE DEVICE NON-FUNCTIONAL. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 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. D9: DATE DEVICE RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    REPORTER IS JNJ REPRESENTATIVE. 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 AN UNKNOWN DATE, THE HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR WAS NOT FUNCTIONAL BEFORE THE CASE STARTED. THE RETENTION KNOB (BLACK KNOB) ON TOP OF THE HANDLE FOR PROTECTION SLEEVE IS BROKEN AND NOT ABLE TO FUNCTION PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113434 HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.430 T982288 10886982068712

    Patients

    Seq Age Sex Outcome Treatment
    1