BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3140693 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01832
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 FIXATION PEGS 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 TWO FIXATION PEGS DISASSOCIATED FROM THE BLOCK, AND DEVICE EVALUATION UNDER MAGNIFICATION CONCLUDED THAT THERE WAS NO EVIDENCE OF AN INTERFERENCE FIT BETWEEN THE MISSING PEGS AND THE BLIND HOLES. 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 PEGS DISASSOCIATING FROM THE TRIATHLON 4:1 CUTTING BLOCK WAS CAUSED BY A MANUFACTURING NONCONFORMANCE. BASED UPON THE CONCLUSIONS OF THE VISUAL ANALYSIS, IT WAS CONCLUDED THAT THE SUPPLIER, (B)(4), 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

    IT WAS REPORTED THAT WHILE IN PRIMARY KNEE CASE. USED A CAPTURED FEMORAL CUTTING BLOCK PUT IN A 5 AND WHILE GOING TO CUT THE SIZE THE DOCTOR CHANGED HIS MIND. WENT TO PULL OUT OF CUTTING BLOCK AND FEMORAL IMPACTOR AND TWO PINS SNAPPED OFF AND STAYED IN PATIENT. THE SURGEON USED VICE GRIP AND PULLED THEM OUT. GRABBED ANOTHER SIZE 4 BLOCK AND CUT WHEN COMPLETED AND PULLED OUT AGAIN ONE OF THE PINS GOT SNAPPED OFF IN THE BONE AGAIN. SURGEON REMOVED PIN AND CLOSED UP AND FINISHED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN PRIMARY KNEE CASE. USED A CAPTURED FEMORAL CUTTING BLOCK PUT IN A 5 AND WHILE GOING TO CUT THE SIZE THE DOCTOR CHANGED HIS MIND. WENT TO PULL OUT OF CUTTING BLOCK AND FEMORAL IMPACTOR AND TWO PINS SNAPPED OFF AND STAYED IN PATIENT. THE SURGEON USED VICE GRIP AND PULLED THEM OUT. GRABBED ANOTHER SIZE 4 BLOCK AND CUT WHEN COMPLETED AND PULLED OUT AGAIN ONE OF THE PINS GOT SNAPPED OFF IN THE BONE AGAIN. SURGEON REMOVED PIN AND CLOSED UP AND FINISHED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242111 SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other