BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM

    MDR report key: 6970057 · Received October 23, 2017

    Report

    Report Number
    0009610622-2017-00334
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 21, 2017
    Report Date
    January 12, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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

    THE EVALUATION REVEALED ALL REAMER SHAFTS TO BE THE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DIMENSIONAL, VISUAL OR MANUFACTURING RELATED ISSUES WERE FOUND. THE REPORTED EVENT WAS CONFIRMED; TWO OF THE PROVIDED REAMER SHAFTS WERE FOUND BROKEN AT THEIR LAST SPIRAL WINDINGS NEAR THE ADAPTER. THE SHAFT WITH LOT CODE K01D688 WAS FOUND COMPLETELY BROKEN (OUTER AND INNER SPIRAL); ONLY THE OUTER SPIRAL WAS FOUND BROKEN OF THE SHAFT WITH LOT CODE K0CDD99. THE BREAKAGE SURFACES AND BREAKAGE LINES SHOW THE TYPICALLY STRUCTURE OF A GLIDING FRACTURE DUE TO A TORSIONAL OVERLOAD DURING OPERATING IN CLOCKWISE DIRECTION (OUTER SPIRALS WERE NOT FOUND UNWINDED). MATERIAL FRAGMENTATION OF THE SHAFTS WERE NOT VISIBLE; MOST LIKELY THE DOVETAIL PEGS OF THE USED BIXCUT HEAD GOT BROKEN. THE USED BIXCUT HEAD WAS NOT PROVIDED FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THE EXTREMITY BROKE, FURTHERMORE MATERIAL GOT FRAGMENTED AND FALL INTO THE PATIENT. THIS INFORMATION IN COMBINATION WITH THE FOUND TORSIONAL OVERLOAD IN CLOCKWISE DIRECTION INDICATE THAT THE USED REAMER HEAD GOT STUCK WITHIN THE BONE CHANNEL (I.E. DENSE CORTICAL BONE). DUE TO OPERATING THE JAMMED REAMER SHAFTS THE SPIRAL MATERIAL GOT OVERLOADED AND BROKE. MOST LIKELY THE CUSTOMER USED A TOO BIG BIXCUT HEAD DIAMETER. THE OPERATIVE TECHNIQUE INCLUDES THAT REAMING SHALL BE PERFORMED IN 0.5 MM STEPS. FURTHERMORE, THE IFU INCLUDES THAT ALL INSTRUMENTS SHALL BE HANDLED WITH CARE; ONLY SHARP DRILLS SHALL BE USED. ALL SHAFTS SHOW SIGNS OF USAGE; IT CANNOT BE EXCLUDED THAT THE SHAFTS WERE USED MULTIPLE TIMES. THE SHAFTS WERE LABELED AS SINGLE USE ITEMS. BASED ON THE GIVEN INFORMATION A MANUFACTURER RELATED ISSUE CAN BE EXCLUDED; THE CASE IS ATTRIBUTED TO AN INADEQUATE USAGE (USER RELATED). REVIEW OF COMPLAINT HISTORY, CAPA DATABASES, LABELLING AND RISK ANALYSIS DID NOT IDENTIFY ANY DISCREPANCIES. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT(S). NO NON-CONFORMITY WAS IDENTIFIED. THE FULL INVESTIGATION REPORT IS ATTACHED IN THE CONCLUSION.

    Description of Event or Problem · 1

    THE PHARMACIST IN CHARGE REPORTED THE FOLLOWING EVENT : " DURING A SURGERY PERFORMED BY DOCTOR (B)(6). WHEN REAMING THE PATIENT'S FEMUR, THE SPIRAL OF THE REAMER BROKE. THEN THE SURGEON USED A SECOND REAMER WHICH THE SPIRAL BROKE AGAIN BUT ALSO THE EXTREMITY BROKE AND SOME FRAGMENTS FELL INTO THE PATIENT'S FEMUR. SO THE SURGEON MANAGED TO RETRIEVE ALL THE FRAGMENTS WHICH DELAYED THE SURGERY. FINALLY, THE SURGEON USED A THIRD REAMER TO COMPLETE SUCCESSFULLY THE PROCEDURE BUT HE NOTICED THAT AT THE END OF THE PROCEDURE; THE THIRD DEVICE WAS NOT IN A GOOD STATE TOO.

    Description of Event or Problem · 1

    THE PHARMACIST IN CHARGE REPORTED THE FOLLOWING EVENT : " DURING A SURGERY PERFORMED BY DOCTOR (B)(6). WHEN REAMING THE PATIENT'S FEMUR, THE SPIRAL OF THE REAMER BROKE. THEN THE SURGEON USED A SECOND REAMER WHICH THE SPIRAL BROKE AGAIN BUT ALSO THE EXTREMITY BROKE AND SOME FRAGMENTS FELL INTO THE PATIENT'S FEMUR. SO THE SURGEON MANAGED TO RETRIEVE ALL THE FRAGMENTS WHICH DELAYED THE SURGERY. FINALLY, THE SURGEON USED A THIRD REAMER TO COMPLETE SUCCESSFULLY THE PROCEDURE BUT HE NOTICED THAT AT THE END OF THE PROCEDURE; THE THIRD DEVICE WAS NOT IN A GOOD STATE TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747470 REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K01D688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other