BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.

    MDR report key: 3023937 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01127
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FIXATION PEG DISASSOCIATING FROM A SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED FIXATION PEG DISASSOCIATING FROM THE TRIATHLON 4:1 EXPRESS CUTTING BLOCK WAS LIKELY CAUSED BY A MANUFACTURING NONCONFORMANCE. INSPECTION OF THE REPORTED DEVICE WOULD BE REQUIRED FOR CONFIRMATION. IT WAS CONCLUDED FROM THE SCOPE OF CAPA THAT THE SUPPLIER HAD NOT PERFORMED THE REQUIRED PRESS FIT OPERATION BETWEEN THE PEG AND BLOCK AND HAD REAMED THE CUTTING BLOCK HOLE OVERSIZED WHICH LED TO THE PIN COMING OUT OF THE ASSEMBLY. NONCONFORMANCE PR WAS RAISED FOR THIS AND SEVERAL OTHER CONCURRENT INVESTIGATIONS WHICH CONFIRMED THE OVERSIZED FIXATION PEG HOLES AND LACK OF PRESS FIT BETWEEN THE FIXATION PEG AND TRIATHLON CUTTING BLOCK.

    Description of Event or Problem · 1

    UPON REMOVING #5 4-IN-1 CUTTING BLOCK. NOTICED THAT A FIXATION PEG BECAME DISLODGED FROM BLOCK. WAS REMOVED WITH A SET OF PLIERS.

    Description of Event or Problem · 1

    UPON REMOVING #5 4-IN-1 CUTTING BLOCK. NOTICED THAT A FIXATION PEG BECAME DISLODGED FROM BLOCK. WAS REMOVED WITH A SET OF PLIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126203 SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SB3M35

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other