BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL IMPACTOR/POSTIONER

    MDR report key: 4860773 · Received June 22, 2015

    Report

    Report Number
    0002249697-2015-02028
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 28, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING EXCESSIVE THREAD LENGTH INVOLVING A UNIVERSAL ACETABULAR SHELL IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE APPEARS TO BE IN USED BUT GOOD CONDITION. IN ADDITION, DIMENSIONAL INSPECTION CONFIRMED THAT THE THREADED STUD PROTRUSION PAST THE IMPACTION SHOULDER FEATURE OF THE HANDLE ASSEMBLY WAS NOT WITHIN SPECIFICATION. MEDICAL RECORDS RECEIVED AND EVALUATION: CLINICIAN REVIEW WAS NOT PERFORMED AS THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO PATIENT FACTORS. DEVICE HISTORY REVIEW: -DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. CONCLUSIONS: THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE HAS BEEN PREVIOUSLY INVESTIGATED AND AN NC WAS OPENED ON MAR-2015 TO FURTHER INVESTIGATE THE OBSERVED NON-CONFORMANCE. CORRECTIVE ACTION/PREVENTIVE ACTION: AN NC HAS BEEN RAISED TO FURTHER INVESTIGATE THE OBSERVED MANUFACTURING NON-CONFORMANCE AT (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OR THE SURGEON WANTED TO PLACE THE CUP, BUT THEN NOTICED THAT THE SCREW-THREAD WAS TOO LONG. ORTHOPAEDIC SURGEON PLACED THE CUP, THEN THE CUP WAS NOT STABLE. THEY SAW THAT THE SCREW-THREAD WAS TO LONG AND SAW THERE WAS A FRACTURE IN THE ACETABULUM. ANOTHER INSTRUMENT SET WAS OPENED TO COMPLETE THE SURGERY. THE PATIENT MUST NOW STAY AT LEAST 6 WEEKS WITHOUT WEIGHT LOADING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OR THE SURGEON WANTED TO PLACE THE CUP, BUT THEN NOTICED THAT THE SCREW-THREAD WAS TOO LONG. ORTHOPAEDIC SURGEON PLACED THE CUP, THEN THE CUP WAS NOT STABLE. THEY SAW THAT THE SCREW-THREAD WAS TO LONG AND SAW THERE WAS A FRACTURE IN THE ACETABULUM. ANOTHER INSTRUMENT SET WAS OPENED TO COMPLETE THE SURGERY. THE PATIENT MUST NOW STAY AT LEAST 6 WEEKS WITHOUT WEIGHT LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402919 UNIVERSAL IMPACTOR/POSTIONER INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH SMM9A12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other