BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IM REAMER, AO FITTING BIXCUT Ø9,5X480 MM

    MDR report key: 3223473 · Received July 12, 2013

    Report

    Report Number
    0009610622-2013-00380
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BENDING OF THE REAMERS WAS CONFIRMED, NOT THE STRESS CORROSION. EVALUATION REVEALED ALL REAMERS TO BE PRIMARY PRODUCTS. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICES HAD BEEN IN USE FOR A MINIMUM OF 1,5 YEARS (02256090) WE PRE-SUPPOSE THAT THE REAMERS HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE BEND SHAFTS AND DAMAGED HEADS ARE A RESULT OF HIGH LEVEL OF USAGE, OVER BENDING DURING USAGE AND/OR CLEANING AND DRILLING METAL. THESE ISSUES ARE ADDRESSED IN THE IFU. STRESS CORROSION WAS NOT FOUND. IT IS POSSIBLE THAT RESIDUES OF BODY LIQUIDS STAY INSIDE THE REAMER SHAFTS. WITHOUT SUFFICIENT CLEANING THESE RESIDUES GET INCRUSTED DURING STERILIZATION. THEREFORE ADDITIONAL CARE DURING CLEANING IS NECESSARY FOR THE REAMERS. ADDITIONAL INCRUSTED RESIDUES WERE EVALUATED BY A MEDICAL EXPERT. CONCLUSION: THE DIFFICULTIES AND SPECIAL EFFORTS IN CLEANING FLEXIBLE REAMERS ARE WELL KNOWN. IN THE CASE PRESENTED THE ITEMS HAD NOT BEEN SUFFICIENTLY CLEANED BY THE USER PRIOR TO STERILIZATION WHICH CAUSED DEFINITE DAMAGE (INCRUSTATION). CLINICAL APPLICATION OF SUCH CONTAMINATED REAMER SHAFTS WOULD NOT LEAD TO HARM CLINICALLY.¿ BASED ON THE INVESTIGATION RESULTS THE CASE IS ATTRIBUTED TO AN INSUFFICIENT USAGE AND HANDLING. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REAMER ARE BENT AND HAVE STRESS CORROSIONS. MOREOVER REAMING OF THE MEDULLARY CAVITY WAS IMPOSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REAMER ARE BENT AND HAVE STRESS CORROSIONS. MOREOVER REAMING OF THE MEDULLARY CAVITY WAS IMPOSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323062 IM REAMER, AO FITTING BIXCUT Ø9,5X480 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K368733

    Patients

    Seq Age Sex Outcome Treatment
    1 Other