BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #5 4:1 CUTTING BLOCK

    MDR report key: 4221740 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04136
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING PIN DISSOCIATION OF A TRIATHLON 4:1 EXPRESS CUTTING GUIDE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PIN HAD DISSOCIATED FROM THE DEVICE BODY. ADDITIONAL DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT WAS CONFIRMED THE PRODUCT WAS WITHIN SCOPE OF THE ASSOCIATED CAPA. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO PATIENT INFORMATION WAS PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. THIS REVIEW CONFIRMED THE DEVICE WAS MANUFACTURED PRIOR TO CAPA IMPLEMENTATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 3 SIMILAR PREVIOUS REPORTED EVENTS. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE FIXATION PEG DISASSOCIATING FROM THE TRIATHLON 4:1 EXPRESS CUTTING BLOCK WAS CAUSED BY A MANUFACTURING NONCONFORMANCE. IT WAS CONCLUDED THAT THE SUPPLIER, SEABROOK INTERNATIONAL, HAD NOT PERFORMED THE REQUIRED PRESS FIT OPERATION BETWEEN THE PEG AND BLOCK WHICH LED TO THE PIN COMING OUT OF THE ASSEMBLY. STRYKER RESERVES THE RIGHT TO RE-EVALUATE THIS INVESTIGATION IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. AS A RESULT, NONCONFORMANCE PR 98410 WAS PREVIOUSLY RAISED ON APR-2013. THE SUPPLIER INVESTIGATION, SCOPE AND CORRECTIVE ACTIONS ARE DETAILED WITHIN THE NC AND CORRESPONDING CAPA PR.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY THE #5 4-1 CUTTING BLOCK BROKE. SURGEON SAW PIECE IN FEMUR STILL WHEN BLOCK WAS TAKEN OFF.

    Description of Event or Problem · 1

    DURING SURGERY THE #5 4-1 CUTTING BLOCK BROKE. SURGEON SAW PIECE IN FEMUR STILL WHEN BLOCK WAS TAKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702680 #5 4:1 CUTTING BLOCK INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other