BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION (TOWEL) CLAMP

    MDR report key: 4102971 · Received September 19, 2014

    Report

    Report Number
    0002249697-2014-03575
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL INSPECTION: THE RETURNED DEVICE IS IN USED CONDITION WITH MINOR DAMAGES CONSISTENT WITH NORMAL USE. ONE OF THE CLAMP JAWS HAS FRACTURED FROM THE DEVICE. THE FRACTURE SURFACE WAS REVIEWED BY THE MA TEAM AND IT WAS DETERMINED THE DEVICE FRACTURED IN OVERLOAD SIMILAR TO THE DEVICE INVESTIGATED UNDER A SIMILAR INVESTIGATION. THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE OVERTIGHTENING OF THE CLAMP DURING MULTIPLE USES. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LOANER STAFF OF STRYKER (B)(4) NOTICED THE BREAKAGE OF THE TIP OF THE DEVICE AFTER IT WAS RETUREND FROM THE HOSPITAL. THE DEVICE WAS BROKEN DURING TKA, BUT THERE WAS NO ADVERSE CONSEQUENCE AND DELAY IN THE OP.

    Description of Event or Problem · 1

    LOANER STAFF OF STRYKER (B)(4) NOTICED THE BREAKAGE OF THE TIP OF THE DEVICE AFTER IT WAS RETURNED FROM THE HOSPITAL. THE DEVICE WAS BROKEN DURING TKA, BUT THERE WAS NO ADVERSE CONSEQUENCE AND DELAY IN THE OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585001 FIXATION (TOWEL) CLAMP INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH PKYK05

    Patients

    Seq Age Sex Outcome Treatment
    1 Other