BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY SCORPIO NRG FEMORAL PR 4:1 CUTTING BLOCK MONOGRAM STYLE SIZE 7 PER FIL

    MDR report key: 4841728 · Received June 12, 2015

    Report

    Report Number
    0002249697-2015-01912
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    April 8, 2015
    Report Date
    May 15, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PEG DISASSOCIATION INVOLVING A SPECIALTY SCORPIO CUTTING BLOCK WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION CONFIRMED THE EVENT AND THAT THE DEVICE WAS WITHIN SCOPE OF THE NC. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED. -DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER EVENT FOR THE LOT REFERENCED. THE HOLE DIAMETERS WERE FOUND TO BE OUT-OF-SPECIFICATION (OVERSIZED) ACCORDING TO THE DESIGN DRAWING. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE PIN HOLE DIAMETERS WERE MACHINED TO BE OVERSIZED AND THEREFORE OUT-OF-SPECIFICATION. THE OVERSIZED HOLE DIAMETER PREVENTED FROM A FULL PRESS-FIT TO BE ACHIEVED, WHICH IS THE PRIMARY METHOD OF PIN FIXATION TO THE BLOCK. THE LASER WELD AROUND THE PIN IS ONLY FOR SUPPLEMENTAL FIXATION. THESE CONDITIONS LEAD TO THE WELD FAILURE AND THE PIN DISASSOCIATION FROM THE BLOCK. AN NC WAS ISSUED FEB-2015 FOR THE SUPPLIER-RELATED MANUFACTURING NONCONFORMANCES OBSERVED IN THIS INVESTIGATION. THE DEVICE IN THIS INVESTIGATION, MANUFACTURED BY ADVANCED PRECISION, WAS DETERMINED TO BE OUT-OF-SPECIFICATION AS THE PIN HOLE WAS OVERSIZED, THE WELD INSUFFICIENT PER THE DESIGN DRAWING, AND NO PRESS-FIT WAS ACHIEVED AS REQUIRED BY THE DESIGN.

    Description of Event or Problem · 1

    USER FACILITY MADWATCH REPORT # (B)(4) STATED: STRYKER 4 IN 1 CUTTING BLOCK HAS PRONGS IN THE BACK OF THE BLOCK TO KEEP IN PLACE IN THE BONE. WHILE TAKING BLOCK OFF THE BONE, WHICH WAS EXTREMELY HARD, 1 OF THE 2 PRONGS BECAME DETACHED FROM THE BLOCK CAUSING A BREACH IN STERILITY.

    Description of Event or Problem · 1

    (B)(4) STATED: STRYKER 4 IN 1 CUTTING BLOCK HAS PRONGS IN THE BACK OF THE BLOCK TO KEEP IN PLACE IN THE BONE. WHILE TAKING BLOCK OFF THE BONE, WHICH WAS EXTREMELY HARD, 1 OF THE 2 PRONGS BECAME DETACHED FROM THE BLOCK CAUSING A BREACH IN STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386245 SPECIALTY SCORPIO NRG FEMORAL PR 4:1 CUTTING BLOCK MONOGRAM STYLE SIZE 7 PER FIL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH AP5S21

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other