BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE LONG Ø3.2MM FOR BUTTRESS

    MDR report key: 4131276 · Received October 1, 2014

    Report

    Report Number
    0008031020-2014-00454
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE MISSING BALL SPRING COULD BE CONFIRMED, SINCE THE RETURNED DEVICE MATCHED THE REPORTED FAILURE. BASED ON THE INVESTIGATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO A USER RELATED ISSUE. THE REPORTED EVENT WAS PROBABLY CAUSED BY MISHANDLING OF THE DEVICE COMBINED WITH AGING OF THE DEVICE ITSELF. THE VISUAL INSPECTION REVEALED THAT THE BALL SPRING IS MISSING, CONFIRMING THE REPORTED EVENT. FOR THE DEVICE TO HAVE THESE DAMAGES IT IS LIKELY THAT CARELESS HANDLING OF THE INSTRUMENT OCCURRED. NOTE, AS STATED IN THE IFU: ¿SPECIAL COMMENTS FOR APPLICATION: ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY.¿ ADDITIONALLY, THE DEVICE SHOWS SIGNS OF BEING USED MULTIPLE TIMES, AS EVIDENCED IN THE SHIPPED PAINTED STRIP AND DULL DRILL SLEEVE EDGES. GIVEN THAT THE DEVICE WAS MANUFACTURED IN 2005, IT IS LIKELY THAT IT HAS REACHED ITS END OF LIFE. SINCE STRYKER DOESN'T STIPULATE THE MAXIMUM NUMBER OF USES FOR THIS DEVICE, IT IS NECESSARY FOR CORRECT MAINTENANCE AND REGULAR INSPECTIONS TO BE DONE. NOTE, AS STATED IN THE INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE: ¿GUIDELINES TO CHECK PROPER FUNCTIONALITY OF THE MEDICAL DEVICES: STRYKER TRAUMA & EXTREMITIES DOES NOT TYPICALLY SPECIFY THE MAXIMUM NUMBER OF USES FOR REUSABLE MEDICAL DEVICES. THE USEFUL LIFE OF THESE DEVICES DEPENDS ON MANY FACTORS INCLUDING THE METHOD AND DURATION OF EACH USE, AND THE HANDLING BETWEEN USES. CAREFUL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE BEFORE USE IS THE BEST METHOD OF DETERMINING THE END OF SERVICEABLE LIFE FOR THE MEDICAL DEVICE. HOWEVER, FOR CERTAIN INSTRUMENTS END OF LIFE HAS BEEN DEFINED, VERIFIED AND SPECIFIED WITH EITHER A NUMBER OF USES OR AN EXPIRATION DATE.¿ ¿FUNCTIONAL CHECK FOR DRILL GUIDES: DESCRIPTION AND FUNCTION: SOFT TISSUE PROTECTION SLEEVES USED DURING DRILLING. POTENTIAL FAILURE MODES: SCRATCHED OUTER SURFACES, DENTS AT THE SLEEVE TIPS. PREVENTIVE MAINTENANCE: USE AN APPROPRIATE INSTRUMENT SPRAY FOR THE MECHANISM OF ALL MOVING PARTS AND ARTICULATING SURFACES. IN CASE OF FAILURE, THE INSTRUMENT MUST BE REPLACED AND NOT BE USED.¿ 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 FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION 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 THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE BALL SPRING WAS MISSING. THE SURGERY WAS FINISHED WITHOUT USING IT.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE BALL SPRING WAS MISSING. THE SURGERY WAS FINISHED WITHOUT USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611352 DRILL SLEEVE LONG Ø3.2MM FOR BUTTRESS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH K06000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other