BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #7 4:1 CUTTING BLOCK

    MDR report key: 6419656 · Received March 20, 2017

    Report

    Report Number
    0002249697-2017-00959
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 20, 2017
    Report Date
    May 24, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K143393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PIN DISASSOCIATION INVOLVING A 4:1 CUTTING BLOCK WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RETURNED IN USED CONDITION. THE PEG HAS DISASSOCIATED FROM THE DEVICE. THERE ARE MINOR SCRATCHES AND ABRASIONS IN VARIOUS AREAS OF THE DEVICE. ADDITIONAL DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT WAS WITHIN THE SCOPE OF THE CAPA. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE FIXATION PEG DISASSOCIATING FROM THE #6 4:1 CUTTING BLOCK WAS CAUSED BY A MANUFACTURING NONCONFORMANCE. IT WAS CONCLUDED THAT THE SUPPLIER, (B)(4), HAD NOT PERFORMED THE REQUIRED PRESS FIT OPERATION BETWEEN THE PEG AND BLOCK 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PIN ON THE CUTTING BLOCK BROKE. THE SURGEON WOULD NORMALLY USE THE HANDLE TO TAKE IT OFF, BUT AS THE HANDLE WAS UNDER RECALL AND NOT IN THE SET, HE USED A 'TOWEL CLIP' TO REMOVE THE DEVICE. THE PIN CAME OFF AND BECAME STUCK IN THE PATIENT. THE SURGEON WAS ABLE TO USE NIBBLERS TO REMOVE THE PIN. THERE WAS A COUPLE OF MINUTES DELAY AS THE SURGEON TRIED TO REMOVE THE PIN FROM THE FEMUR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PIN ON THE CUTTING BLOCK BROKE. THE SURGEON WOULD NORMALLY USE THE HANDLE TO TAKE IT OFF, BUT AS THE HANDLE WAS UNDER RECALL AND NOT IN THE SET, HE USED A 'TOWEL CLIP' TO REMOVE THE DEVICE. THE PIN CAME OFF AND BECAME STUCK IN THE PATIENT. THE SURGEON WAS ABLE TO USE NIBBLERS TO REMOVE THE PIN. THERE WAS A COUPLE OF MINUTES DELAY AS THE SURGEON TRIED TO REMOVE THE PIN FROM THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199235 #7 4:1 CUTTING BLOCK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH SB3E39

    Patients

    Seq Age Sex Outcome Treatment
    1 Other