BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 10943644 · Received December 4, 2020

    Report

    Report Number
    2939274-2020-05440
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 8, 2020
    Report Date
    November 8, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    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, LOT 180274-101: MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: DECEMBER 28, 2018. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 DURING AN EXPERT TIBIAL NAIL INSERTION PROCEDURE ON NOVEMBER 8, 2020, THE DRILL BIT MADE CONTACT WITH NAIL WHILE DRILLING FOR THE PROXIMAL SCREW. THE DEVICE WAS CHECKED AFTER THE PROCEDURE AND SHOWED EVERYTHING WAS CORRECTLY ALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO (2) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409469 INSERTION HANDLE FOR SUPRAPATELLAR NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 180274-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE| 12.0MM/8.0MM PROTECTION SLEEVE 188MM| 8.0MM/4.2MM DRILL SLEEVE 200MM| AIMING ARM FOR SUPRAPATELLAR| UNK - DRILL BITS: TRAUMA| UNK - SCREWS: TRAUMA| 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE| 12.0MM/8.0MM PROTECTION SLEEVE 188MM| 8.0MM/4.2MM DRILL SLEEVE 200MM| AIMING ARM FOR SUPRAPATELLAR| UNK - DRILL BITS: TRAUMA| UNK - SCREWS: TRAUMA