BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 3830612 · Received May 23, 2014

    Report

    Report Number
    0001811755-2014-01894
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, SILICONE IS VISIBLE, WAS CONFIRMED. UPON DISASSEMBLY A BROKEN O-RING WAS FOUND, WHICH CAUSED THE EVENT. ACCORDING TO A REVIEW OF RISK DOCUMENTATION AND CASES WITH A SIMILAR REPORTED EVENT AN O-RING FAILURE CAN CAUSE A FAILURE RESULTING IN REVERSIBLE INJURIES REQUIRING MEDICAL INTERVENTION. THE DEVICE WAS REPAIRED AND RETURNED AFTER PASSING THE FINAL DEVICE INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 DUAL TRIGGER ROTARY WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE AT THE USER FACILITY. THIS EVENT OCCURRED DURING VISUAL INSPECTION, SO THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 DUAL TRIGGER ROTARY WAS ALLEGEDLY LEAKING AN UNKNOWN SUBSTANCE AT THE USER FACILITY. THIS EVENT OCCURRED DURING VISUAL INSPECTION, SO THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308395 SYSTEM 7 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1