BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3140529 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01828
    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

    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. VISUAL EVALUATION SHOWED THE DEVICE WAS RETURNED WITH ONE FIXATION PEG DISASSOCIATED FROM THE BLOCK, AND DEVICE EVALUATION UNDER MAGNIFICATION CONCLUDED THAT THERE WAS NO EVIDENCE OF AN INTERFERENCE FIT BETWEEN THE MISSING PEG AND THE BLIND HOLE. NO PATIENT INFORMATION WAS PROVIDED FOR REVIEW. THE INVESTIGATION CONCLUDED THAT THE FIXATION PEG 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. STRYKER RESERVES THE RIGHT TO RE-EVALUATE THIS INVESTIGATION IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. THE REPORTED EVENT REGARDING A FIXATION PEG DISASSOCIATING FROM A SIZE #4 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. WAS CONFIRMED.

    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
    240987 SIZE #4 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH SB2V65

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other