BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 125MM

    MDR report key: 11504752 · Received March 17, 2021

    Report

    Report Number
    2939274-2021-01340
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 19, 2021
    Report Date
    February 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982181510
    PMA / PMN Number
    K122455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: LXT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, ONE (1) BROAD LOCKING COMPRESSION PLATE HOLE STRIPPED AND THE LOCKING HOLE DID NOT ENGAGE, ONE (1) BROAD LOCKING COMPRESSION PLATE BROKE AFTER EXCESSIVE BENDING, AND THE PINS OF A EIGHT (8) SHANZ SCREW BLUNTED TROCAR POINT HAD A BROKEN TIPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THREE (3) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 125MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398239 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 125MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 294.53 10886982181510

    Patients

    Seq Age Sex Outcome Treatment
    1 4.5MM BROAD LCP® PLATE 7 HOLES/134MM.| 4.5MM BROAD LCP® PLATE 8 HOLES/152MM.| 5.0MM SCHANZ SCREW 100MM.| 5.0MM SCHANZ SCREW 125MM.