BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL STEM INSERTER

    MDR report key: 3022713 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01076
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AND WAS NOT RETURN TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD AND COMPLAINT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT WAS PROVIDED. A VISUAL INSPECTION FROM THE PROVIDED PHOTO SHOWS A DISASSEMBLED STEM INSERTER HANDLE FROM THE THREADED ROD. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT A SUGGESTION AND COMPARISON OF THE ¿OLD STYLE¿ DISTAL INSERTER VS. ¿NEW STYLE¿ DISTAL INSERTER WAS CAUSED BY AN UNAUTHORIZED DISASSEMBLY OF THE DEVICE DURING CLEANING AND STERILIZATION. AN ENGINEERING CHANGE WAS ISSUED TO DRIVE A DESIGN IMPROVEMENT TO CORRECT THIS REOCCURRING ISSUE, AND THE INTERNAL GEOMETRY OF THE INSERTER WAS MODIFIED TO A ¿NEW STYLE¿ THAT WILL AID WITH THE CLEANING AND STERILIZATION.

    Description of Event or Problem · 1

    ORTHOPAEDIC SURGEON (B)(6) REPORTED TO SALES REP (B)(4) THAT THE CLEANING AND STERILISATION INSTRUCTIONS FOR THE "OLD STYLE" DISTAL STEM INSERTER ARE INADEQUATE BECAUSE THERE IS NO SPECIFIC INSTRUCTION REGARDING THE DISASSEMBLY OF THE INSTRUMENT PRIOR TO CLEANING AND STERILISATION. (B)(6) SHOWED (B)(4) A DISTAL STEM INSERTER WHICH HAD BEEN RETURNED FROM THEIR OFF SITE DECONTAMINATION UNIT - (B)(4). ON DISASSEMBLY, (B)(6) ALLEGED THAT THE INSTRUMENT STILL CONTAINED BLOOD AND BONE REMNANTS. IT HAS BEEN REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION SINCE IT HAS BEEN SENT AWAY FOR DISPOSAL BUT THE DEVICE HAS BEEN PHOTOGRAPHED. WE ARE TRYING TO GET HOLD OF COPIES OF THE PHOTOGRAPHS. (B)(6) INDICATED THAT THE LATEST DESIGN OF DISTAL STEM INSERTER DOES INCLUDE AN INSTRUCTION ABOUT DISASSEMBLY AND IS QUESTIONING WHY THE OLD STYLE INSTRUMENT DOES NOT HAVE THE SAME INSTRUCTIONS AS THE NEW STYLE INSTRUMENT. SALES REP (B)(4) REPORTED THAT THE HOSPITAL POSTPONED ALL PLANNED ORTHOPAEDIC SURGERIES LAST MONTH DUE TO GENERAL CONCERNS OVER THE QUALITY AND QUANTITY OF INSTRUMENTS COMING FROM THE DECONTAMINATION UNIT AT (B)(4). IT WAS REPORTED THAT MORE THAN 200 PROCEDURES WERE AFFECTED. THE ISSUES HAVE BEEN FRONT PAGE NEWS LAST WEEK IN (B)(6) IN LOCAL NEWSPAPERS AND HAS ALSO BEEN REPORTED IN THE LOCAL TV NEWS AND ON (B)(6).

    Description of Event or Problem · 1

    ORTHOPAEDIC SURGEON (B)(6) REPORTED TO SALES REP (B)(4) THAT THE CLEANING AND STERILISATION INSTRUCTIONS FOR THE "OLD STYLE" DISTAL STEM INSERTER ARE INADEQUATE BECAUSE THERE IS NO SPECIFIC INSTRUCTION REGARDING THE DISASSEMBLY OF THE INSTRUMENT PRIOR TO CLEANING AND STERILISATION. (B)(6) SHOWED (B)(4) A DISTAL STEM INSERTER WHICH HAD BEEN RETURNED FROM THEIR OFF SITE DECONTAMINATION UNIT - (B)(6). ON DISASSEMBLY, (B)(6) ALLEGED THAT THE INSTRUMENT STILL CONTAINED BLOOD AND BONE REMNANTS. IT HAS BEEN REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION SINCE IT HAS BEEN SENT AWAY FOR DISPOSAL BUT THE DEVICE HAS BEEN PHOTOGRAPHED. WE ARE TRYING TO GET HOLD OF COPIES OF THE PHOTOGRAPHS. (B)(6) INDICATED THAT THE LATEST DESIGN OF DISTAL STEM INSERTER DOES INCLUDE AN INSTRUCTION ABOUT DISASSEMBLY AND IS QUESTIONING WHY THE OLD STYLE INSTRUMENT DOES NOT HAVE THE SAME INSTRUCTIONS AS THE NEW STYLE INSTRUMENT. SALES REP (B)(4) REPORTED THAT THE HOSPITAL POSTPONED ALL PLANNED ORTHOPAEDIC SURGERIES LAST MONTH DUE TO GENERAL CONCERNS OVER THE QUALITY AND QUANTITY OF INSTRUMENTS COMING FROM THE DECONTAMINATION UNIT AT (B)(6). IT WAS REPORTED THAT MORE THAN 200 PROCEDURES WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125125 DISTAL STEM INSERTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other