BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION SHEATH FOR 62-20135, MMF SCREW DRIVER

    MDR report key: 5324313 · Received December 23, 2015

    Report

    Report Number
    0008010177-2015-00328
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    December 11, 2015
    Report Date
    July 21, 2020
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: WHEN THE INITIAL REPORT WAS SENT TO THE FDA (B)(4), IT WAS MISTAKENLY INDICATED THAT IT WAS A FOLLOW-UP REPORT. CONSEQUENTLY, WHEN THE ACTUAL SUPPLEMENTAL WAS FILED, IT WAS INDICATED TO BE A FOLLOW-UP REPORT #2 (B)(4). "30-DAY (INITIAL) MDR" WAS NEVER SELECTED, AND THIS WAS NOTICED BY AN EMPLOYEE OF THE FDA MEDWATCH PROGRAM. THIS REPORT IS INDICATED AS AN INITIAL REPORT, PER THE REQUEST SENT TO OUR DIVISION. IT CONTAINS ALL DATA THAT WAS INCLUDED ON THE FIRST TWO REPORTS. DEVICE EVALUATION: UPON RECEIPT OF THE DEVICE, IT WAS DETERMINED THAT THE AFFECTED COMPONENT ARTICLE NUMBER WAS ACTUALLY 01-03017, NOT 01-03016. THE REPORTED EVENT THAT THE GRASPING COMPONENTS OF THE TENSIONING PLIERS SYSTEM BROKE COULD BE CONFIRMED. WITHIN THE VISUAL INSPECTION OF THE RETURNED TENSION PLIERS IT WAS DETERMINED THAT AT THE GRASPING AREA ALL THREE GRASPING COMPONENTS HAVE BEEN BROKEN OFF RESULTING FROM AN INAPPROPRIATE USER HANDLING IN COMBINATION WITH TOO HIGH FORCES. FURTHERMORE, EACH GRASPING COMPONENT SHOWED SECONDARY CRACKS AT THE BREAKAGE AREA RESULTING FROM BENDING OVERLOAD DUE TO AN INAPPROPRIATE USER HANDLING. A HANDLING TEST OF THE TENSION PLIERS SYSTEM PERFORMED WITH THE RETURNED SCREWDRIVER BLADE, TENSION PLIERS AND TENSION SHEATH REVEALED THAT THE ASSEMBLING OF THE BROKEN TENSION PLIERS INTO THE TENSION SHEATH AND TO THE SCREWDRIVER BLADE DOES NOT FUNCTION. BASED ON INVESTIGATION THE ROOT CAUSE OF THE BROKEN OFF GRASPING COMPONENTS OF THE TENSION PLIERS WAS ATTRIBUTED TO AN INAPPROPRIATE USER HANDLING IN COMBINATION WITH BENDING OVERLOAD. ACCORDING TO THIS, EITHER AN IMPROPER ASSEMBLY OF THE COMPONENTS OF THE TENSION PLIERS SYSTEM IN COMBINATION WITH TOO HIGH FORCES CAUSED THE BREAKAGE OR BENDING OVERLOAD WAS TRANSMITTED TO THE GRASPING COMPONENTS DURING APPLICATION. INDICATIONS FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. THEREFORE NO PREVENTIVE AND/OR CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT THE GRASPING PORTION OF THE SCREWDRIVER SHEATH BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850660 TENSION SHEATH FOR 62-20135, MMF SCREW DRIVER INSTRUMENT LXH STRYKER LEIBINGER FREIBURG AE06

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown