BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 12256524 · Received July 30, 2021

    Report

    Report Number
    2939274-2021-04414
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 2, 2021
    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
    CA, 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. H3, H4, H6: PART # 03.010.440-US. LOT # 190164-101. MANUFACTURING SITE: SELZACH. RELEASE TO WAREHOUSE DATE: 05 JAN2018. SUPPLIER: LEITNER AG. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE INSERTION HANDLE FOR SUPRAPATELLAR (P/N: 03.010.440, LOT NUMBER: 190164-101) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, NO DAMAGE WAS OBSERVED. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE AND THE RETURNED MATING DEVICE. THE DEVICES CAN ASSEMBLE AND DISASSEMBLE, BUT WITH DIFFICULTY. THUS THE REPORTED CONDITION CAN BE REPLICATED. DIMENSIONAL INSPECTION: COMPLAINT RELEVANT DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DEVICE GEOMETRY. DOCUMENT/SPECIFICATION REVIEW: MANUFACTURED AND CURRENT WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE HAS DIFFICULTY ASSEMBLING TO THE MATING DEVICE. 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 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 COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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) 2021, DURING AN INTRAMEDULLARY RODDING OF A TIBIA, IT WAS DISCOVERED THAT ATTACHMENT OF THE DEPUY SYNTHES SUPRAPATELLAR AIMING ARM WAS DIFFICULT TO ATTACH TO THE CORRESPONDING INSERTION HANDLE INTRA-OPERATIVELY. A MALLET WAS REQUIRED TO SEAT THE AIMING DEVICE APPROPRIATELY TO THE INSERTION HANDLE. UPON INSPECTION, IT APPEARS THE DOWELS ON THE AIMING ARM ARE OUT OF ALIGNMENT. THERE WAS NO SURGICAL DELAY. THE CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148762 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 90164-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 AIMING ARM FOR SUPRAPATELLAR| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA