BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 12617953 · Received October 12, 2021

    Report

    Report Number
    2939274-2021-06011
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 14, 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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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, H6: PART: 03.010.440-US, LOT: 190164-101, MANUFACTURING SITE: SELZACH, RELEASE TO WAREHOUSE DATE: JANUARY 05, 2018, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE INSERTION HANDLE FOR SUPRAPATELLAR WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO DEFECT. FUNCTIONAL TEST: THE COMPLAINT DEVICE WAS ASSEMBLED WITH THE RETUNED CONNECTION SCREW. NO ISSUE WAS OBSERVED. AS THE OTHER APPLICABLE MATING DEVICES WERE NOT RETURNED, A FULL FUNCTIONAL ASSESSMENT WAS NOT ABLE TO BE PERFORMED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO THE NATURE OF THE COMPLAINT. ALSO THERE WAS NO DEFECT PERTAINING TO THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THERE WAS NO DAMAGE OR ISSUE OBSERVED THAT COULD HAVE CONTRIBUTE TO THE REPORTED ALLEGATION. ALSO THE DEVICE RECEIVED WAS NOT ASSEMBLED OR UNABLE TO BE SEPARATED FROM MATING DEVICE. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. 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 PREVENTIVE 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 · 0

    THE SUBJECT 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE INSERTION OF THE NAIL, THE TARGETING ARM, STATIC ARM SCREW WAS NOT ABLE TO INSERT IN THE NAIL SO IT HAD TO BE REMOVED AND INSERT MANUALLY. UPON REMOVAL OF THE INSERTION HANDLE FROM THE NAIL, THE SURGEON COULD NOT GET THE INSERTION BOLT OUT OF THE NAIL. HAMMER WAS USED TO REMOVE THE INSERTION HANDLE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513906 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 190164-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Unknown AIMING ARM FOR SUPRAPATELLAR| CANN CONNECTING SCR F/PERCUTAN INSTS NL| UNK - NAILS