BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM-STERILE

    MDR report key: 7508552 · Received May 11, 2018

    Report

    Report Number
    2939274-2018-52142
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 14, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982094933
    PMA / PMN Number
    K040762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. DEVICE WAS NOT EXPLANTED. 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. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO.: 04.034.234S, LOT NO.: 7142064, MANUFACTURING LOCATION: SELZACH SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 10.JAN.2013 , EXPIRY DATE: 25.DEC.2021. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 04.034.234 / 7142064 WAS MANUFACTURED IN US, MONUMENT. MANUFACTURING LOCATION: (B)(4), PACKAGED BY: MONUMENT MANUFACTURING DATE: 18-DEC-2012 PART #: 04.034.234, LOT#: 7142064 (NON-STERILE) - 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM. QTY: 6. COMPONENTS: RAW MATERIAL PART 21012, LOT: 6839555. RAW MATERIAL SUPPLIED FROM DYNAMET INCORPORATED. DYNAMET CERTIFICATE OF COMPLIANCE MEET SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE SURGEON COULD NOT DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE IMPLANTED TITANIUM CANNULATED TIBIAL NAIL. SURGEON WAS ABLE TO USE A SCREWDRIVER AND OPEN END WRENCH TO REMOVE THE CONNECTING SCREW. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THIS COMPLAINT IS FOR A 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349508 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM-STERILE NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.034.234S 7142064 10886982094933

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR