BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL IMPACTOR/POSTIONER

    MDR report key: 3931650 · Received July 14, 2014

    Report

    Report Number
    0002249697-2014-02702
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING STRIPPED THREADS INVOLVING A UNIVERSAL IMPACTOR/POSITIONER WAS REPORTED. THE EVENT WAS CONFIRMED. IT IS NOT BELIEVED THAT PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS OF THE RETURNED PART HAD MATERIAL DAMAGE TO THE THREADED STUD. THE THREADS ON THE STUD WERE DEFORMED AND FRACTURED FROM THE STUD. THE STUD WAS LIKELY NOT COMPLETELY SCREWED INTO THE SHELL DURING IMPACTION. A MAR CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE REPORTED THREAD DAMAGE ON THE IMPACTOR WAS CONFIRMED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED AS THE RETURNED PART HAD MATERIAL DAMAGE TO THE THREADED STUD. THE THREADS ON THE STUD WERE DEFORMED AND FRACTURED FROM THE STUD. HOWEVER THE DAMAGE IS CONSISTENT WITH USAGE OF THE DEVICE WITHOUT FULLY THREADING THE TRIAL OR SHELL TO THE IMPACTION HANDLE DURING IMPACTION.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED VIA THE (B)(4), THAT WHILST USING A TRIDENT ACETABULAR CUP INTRODUCER, THREADS FROM THE INTRODUCER WERE ALLEGEDLY SHEARING OFF WHEN TORQUE WAS APPLIED. THE CUSTOMER HAS REPORTED THAT SHARDS OF METAL WERE ALLEGEDLY FOUND IN THE PATIENTS WOUND. ADDITIONAL INFORMATION: THE SURGEON REMOVED SHARDS AND IS SATISFIED THAT NOTHING SHOWED UP ON POST OPERATIVE X RAYS. HE DID NOT HAVE TO ADD ANY TIME TO SURGERY, AND HE WAS HAPPY WITH THE OUTCOME. NO OTHER INSTRUMENTS WERE REQUIRED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED VIA THE NIAIC, THAT WHILST USING A TRIDENT ACETABULAR CUP INTRODUCER, THREADS FROM THE INTRODUCER WERE ALLEGEDLY SHEARING OFF WHEN TORQUE WAS APPLIED. THE CUSTOMER HAS REPORTED THAT SHARDS OF METAL WERE ALLEGEDLY FOUND IN THE PATIENTS WOUND. ADDITIONAL INFORMATION: THE SURGEON REMOVED SHARDS AND IS SATISFIED THAT NOTHING SHOWED UP ON POST OPERATIVE X-RAYS. HE DID NOT HAVE TO ADD ANY TIME TO SURGERY, AND HE WAS HAPPY WITH THE OUTCOME. NO OTHER INSTRUMENTS WERE REQUIRED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410889 UNIVERSAL IMPACTOR/POSTIONER INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH SMM7C02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other