BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3051334 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01238
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 CONFIRMED. VISUAL EVALUATION SHOWED THE DEVICE WAS RETURNED WITH ONE FIXATION PEG DISASSOCIATED FROM THE BLOCK, AND THERE WAS NO EVIDENCE OF AN INTERFERENCE FIT ON THE BLIND HOLE. DIMENSIONAL ANALYSIS DETERMINED THAT THE CUTTING BLOCK HOLE WAS OVERSIZED. NO PATIENT INFORMATION WAS PROVIDED FOR REVIEW. 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 FIXATION PEG DISASSOCIATING FROM THE TRIATHLON 4:1 EXPRESS CUTTING BLOCK WAS CAUSED BY A MANUFACTURING NONCONFORMANCE. BASED UPON THE CONCLUSIONS OF THE VISUAL AND DIMENSIONAL ANALYSIS, IT WAS CONCLUDED THAT THE SUPPLIER, (B)(6), 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.

    Description of Event or Problem · 1

    DOCTOR MADE HIS FOUR IN ONE CUT WITH THE BLOCK 6541-1-705E, LOT SB3E47. UPON REMOVAL OF THE BLOCK, ONE OF THE PEGS CAME OFF OF THE BLOCK. THE PEG REMAINED IN THE BONE. THE DOCTOR TOOK A PAIR OF VICE GRIPS ATTACHED IT TO THE PIN AND REMOVED IT.

    Description of Event or Problem · 1

    DOCTOR MADE HIS FOUR IN ONE CUT WITH THE BLOCK (B)(4) LOT SB3E47. UPON REMOVAL OF THE BLOCK ONE OF THE PEGS CAME OFF OF THE BLOCK. THE PEG REMAINED IN THE BONE. THE DOCTOR TOOK A PAIR OF VICE GRIPS ATTACHED IT TO THE PIN AND REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149623 SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SB3E47

    Patients

    Seq Age Sex Outcome Treatment
    1 Other