BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPOSITIONING FORCEPS JAW: BALLSPIKE L135MM

    MDR report key: 6428974 · Received March 23, 2017

    Report

    Report Number
    0008031020-2017-00154
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    January 27, 2017
    Report Date
    June 6, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT REPOSITIONING FORCEPS JAW: BALLSPIKE L135 MM WAS ALLEGED OF 'BREAKAGE DURING SURGERY' COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY THE APPLICATION OF EXCESSIVE FORCE ON THE FORCEPS. THE DEVICE INSPECTION REVEALED THAT ONE OF THE HANDLES IS BROKEN AND THE SCREW THAT UNITED THE 2 HANDLES IS DISASSEMBLED AND DEFORMED. THE BREAKAGE SURFACES ARE CONSISTENT WITH BREAKAGE DUE TO A HIGH FORCE APPLICATION. WHEN THE HANDLE BROKE, THE SCREW DEFORMED AND THE DEVICE WAS DISASSEMBLED. MOREOVER, IT WAS REPORTED THAT THE FORCEPS WERE USED FOR TORQUE, WHICH IS NOT THE PURPOSE OF THE FORCEPS. ITS PURPOSE IS FOR REDUCTION OF FRAGMENTS ONLY. NOTE, AS STATED IN THE IFU (V15011): ''2 SPECIAL COMMENTS FOR APPLICATION. ONLY USE AN INSTRUMENT FOR ITS INTENDED PURPOSE. IMPROPER USE OF INSTRUMENTS MIGHT LEAD TO LOSS IN FUNCTION OR USAGE. ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY. THE DESIGN OF THE INSTRUMENT MUST NOT BE MODIFIED IN ANY WAY.'' [ORIGINAL STATEMENT(S)]. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING A FRACTURE PROCEDURE (SMALL FRAGMENTS), THE INSTRUMENT WAS DAMAGED.

    Description of Event or Problem · 1

    DURING A FRACTURE PROCEDURE (SMALL FRAGMENTS), THE INSTRUMENT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209790 REPOSITIONING FORCEPS JAW: BALLSPIKE L135MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH Z10020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other