BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL IMPACTOR/POSTIONER

    MDR report key: 6935376 · Received October 10, 2017

    Report

    Report Number
    0002249697-2017-02955
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 6, 2017
    Report Date
    January 15, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K161569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ADVERSE EVENT/PRODUCT PROBLEM; OUTCOMES ATTRIBUTED TO AE; TYPE OF REPORTABLE EVENT. AN EVENT REGARDING SIZE/FIT ISSUE INVOLVING A TRIDENT IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. DIMENSIONAL INSPECTION CONFIRMED THAT THE THREADED STUD PROTRUSION PAST THE IMPACTION SHOULDER FEATURE OF THE HANDLE ASSEMBLY WAS NOT WITHIN SPECIFICATION. THE THREADED STUD SHOULD PROTRUDE .130, ± .005. THE PROTRUSION WAS MEASURED AND FOUND TO BE OUT BY +.110, THEREBY INDICATING THAT IT IS OUT OF SPECIFICATION. THE LENGTH OF THE THREADED STUD SHOULD BE .875 ± .005. THE LENGTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION AT .8755. ALSO, TECH SERVICES INDICATED WHEN THEY DRILLED THE SHAFT AT THE DOWEL PIN LOCATION OF .373, THE PIN WAS NOT THERE. THE ACTUAL PIN LOCATION WAS APPROXIMATELY AT .273. MATERIAL ANALYSIS CONCLUDED, "THE CUP IMPACTOR FRACTURED IN OVERLOAD. THE DISTANCE BETWEEN THE BOTTOM OF THE SHAFT OPENING AND THE THREADED STUD WAS REPORTED TO BE 0.002 IN. BASED ON VISUAL EXAMINATION OF THE SHAFT HANDLE AND THREADED STUD, A PRESS FIT CONDITION WAS ACHIEVED. THE DOWEL PIN WAS DAMAGED; A FRACTURE SURFACE ANALYSIS AND ORIGINAL LOCATION EVALUATION COULD NOT BE PERFORMED. EDS WAS PERFORMED ON THE SHAFT AND FOUND TO BE CONSISTENT WITH 17-4 PH STAINLESS STEEL. THE SHAFT HARDNESS OF HRC 44 MEETS DRAWING REQUIREMENTS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED." MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. NO OTHER EVENTS WERE REPORTED FOR THE LOT INDICATED. THE REPORTED EVENT WAS CONFIRMED AS THE RETURNED INSTRUMENT WAS MEASURED AND FOUND THE PROTRUSION OF THE THREADED STUD TO BE OUT OF SPECIFICATION. THE MAR CONCLUDED THAT THE CUP IMPACTOR FRACTURED IN OVERLOAD. ALTHOUGH THE DIMENSIONAL REPORT CONFIRMED THE PROTRUSION WAS OUT OF SPECIFICATION, THE MAR NOTED THAT THE STUD WAS SEATED AT THE BOTTOM OF THE SHAFT. THIS PROVIDES EVIDENCE THAT THE DEVICE WAS MANUFACTURED AND ASSEMBLED CORRECTLY INITIALLY AND THAT DURING USE THE PULLOUT OF THE THREADED STUD FROM THE HOLE OCCURRED. BASED ON VISUAL EXAMINATION, A PARTIAL PRESS FIT CONDITION WAS ACHIEVED BETWEEN THE SHAFT HANDLE AND THREADED STUD. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A TRIDENT CUP WAS LOADED ONTO A TRIDENT IMPACTOR AND IMPACTION WAS ATTEMPTED. UPON FAILING TO SEAT THE CUP THE SURGEON REMOVED IT AND NOTICED THAT THE IMPACTOR THREAD WAS TOO LONG AND HAD PROTRUDED THROUGH THE CUP. THE SCRUB NURSE WAS JUNIOR AND INEXPERIENCED, AND DID NOT NOTICE HERSELF. UPDATE: SURGEON NOTICED THE CUP WASN'T SEATED PROPERLY, REMOVED CUP IMPACTOR WITH THE CUP AND NOTICED THE ACETABULUM HAD A SMALL PUNCTURE DEFECT.

    Description of Event or Problem · 1

    A TRIDENT CUP WAS LOADED ONTO A TRIDENT IMPACTOR AND IMPACTION WAS ATTEMPTED. UPON FAILING TO SEAT THE CUP THE SURGEON REMOVED IT AND NOTICED THAT THE IMPACTOR THREAD WAS TOO LONG AND HAD PROTRUDED THROUGH THE CUP. THE SCRUB NURSE WAS JUNIOR AND INEXPERIENCED, AND DID NOT NOTICE HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714322 UNIVERSAL IMPACTOR/POSTIONER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 135315

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other