BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE

    MDR report key: 7394321 · Received April 3, 2018

    Report

    Report Number
    2939274-2018-51426
    Event Type
    Injury
    Date Received
    April 3, 2018
    Report Date
    March 8, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982095534
    PMA / PMN Number
    K040762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS 6¿10¿ DATE OF EVENT: DATE PATIENT PAIN BEGAN IS NOT KNOWN. DATE OF IMPLANT REPORTED AS 5 TO 6 YEARS PRIOR TO EXPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 04-JUN-2009. EXPIRATION DATE: 30-APR-2018. PART #: 04.034.658S, LOT#: 6150903 (STERILE) - 12MM TI CANN TIBIAL NAIL - EX W/PROX BEND 390MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 21012, LOT 5846782 REVIEWED. RAW MATERIAL WAS RECEIVED FROM SUPPLIER (B)(4), CERTIFICATE OF TEST FOR TITANIUM INGOT RECEIVED FROM (B)(4) MEET SPECIFICATION. INSPECTION CERTIFICATE RECEIVED FROM (B)(4) MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUT AWAY CHECKLIST MEETS SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE (B)(4) MET INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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 PATIENT WAS IMPLANTED WITH A TIBIAL NAIL APPROXIMATELY 5 TO 6 YEARS PRIOR TO REMOVAL. ON UNKNOWN DATE, PATIENT REPORTED PAIN. IT WAS DETERMINED THE NAIL WAS RUBBING AGAINST THE PATELLA. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE NAIL AND SCREWS WERE REMOVED FULLY INTACT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS NOT REVISED TO ADDITIONAL HARDWARE AND IS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 12MM CANNULATED TIBIAL NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236562 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.034.658S 6150903 10886982095534

    Patients

    Seq Age Sex Outcome Treatment
    1