BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 8932390 · Received August 26, 2019

    Report

    Report Number
    2939274-2019-60092
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 26, 2019
    Report Date
    July 30, 2019
    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 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. H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440 LOT #170413-301) WAS RECEIVED AT US CQ. THE INSERTION HANDLE WAS RETURNED WITH THE THREADED TIP OF THE DRIVING CAP LODGED INTO IT. THE DEVICE HAD SURFACE SCRATCHES ALONG THE HANDLE BUT SHOWED NO EVIDENCE OF A BREAKAGE. THESE COSMETIC ISSUES ARE CONSISTENT WITH NORMAL WEAR. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. THE INSERTION HANDLE DID NOT HAVE A DEFECT, IT WAS RENDERED INOPERABLE DUE TO THE DRIVING CAP BREAKING AFTER THE DEVICES FELL. THE COMPLAINT IS NOT CONFIRMED FOR THIS DEVICE. CONCLUSION: THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440 LOT #170413-301) AS THERE WAS NO EVIDENCE OF A BROKEN COMPONENT OF THE DEVICE. THERE WERE LIGHT SURFACE SCRATCHES ALONG THE BODY OF THE DEVICE WHICH ARE CONSISTENT WITH NORMAL USE. THE DEVICE WAS RENDERED INOPERABLE DUE TO THE DRIVING CAP BREAKING INTO ITS MATING POINT. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART:03.010.440, LOT: 170413-301, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 02 MARCH 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. REPORTER: SYNTHES EMPLOYEE. 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) 2019 THE DRIVING CAP/THREADED AND INSERTION HANDLE FOR SUPRAPATELLAR WAS BROKEN. IT WASN¿T DURING SURGERY. IT HAPPENED WHEN THE INSTRUMENT FELL ON THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724066 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 170413-301 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1