BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 9690846 · Received February 10, 2020

    Report

    Report Number
    2939274-2020-00773
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Report Date
    January 19, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982068828
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).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.E3: REPORTER IS A SYNTHES REP.H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD.DEVICE HISTORY LOT,PART: 03.010.440,LOT: 160187-101,MANUFACTURING SITE: SELZACH,SUPPLIER: (B)(4),RELEASE TO WAREHOUSE DATE: 08. SEP. 2016.A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.H3, H6: INVESTIGATION SUMMARY BACKGROUND:01/27/2020: UPDATED EVENT DESCRIPTION:IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SUPRAPATELLAR INSERTION HANDLE AND A DRIVING CAP CROSS-THREADED AND WOULD NOT SEAT PROPERLY. THE DRIVING CAP DOES NOT SCREW IN PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.THIS COMPLAINT INVOLVES TWO (2) DEVICES.INVESTIGATION FLOW:DAMAGE.VISUAL INSPECTION:THE INSERTION HANDLE FOR SUPRAPATELLAR (P/N: 03.010.440, LOT #: 160187-101) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE INTERNAL THREADS WERE STRIPPED. THERE WERE SCRATCHES ON THE DEVICE BUT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE.FUNCTIONAL TEST:THE FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED DEVICE.THE DRIVING CAP WAS NOT ABLE TO SCREW IN PROPERLY WHEN THE DRIVING CAP WAS SCREWED INTO THE INSERTION HANDLE. THE COMPLAINT WAS REPLICATED WITH THE RETURNED DEVICES.DIMENSIONAL INSPECTION:NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICEDOCUMENT/SPECIFICATION REVIEWBASED ON THE DATE OF MANUFACTURE, THE DRAWING REFLECTED THE CURRENT AND MANUFACTURED REVISION.THE DEVICE RECEIVED WAS STRIPPED. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE INSERTION HANDLE FOR SUPRAPATELLAR (P/N: 03.010.440, LOT #: 160187-101). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO A DEVICE USED. 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 ACTIVITIESDEVICE 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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, A SUPRAPATELLAR INSERTION HANDLE AND A DRIVING CAP CROSS-THREADED. THE DRIVING CAP DOESN'T SCREW IN PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149784 INSERTION HANDLE FOR SUPRAPATELLAR NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 160187-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1