BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 14MM

    MDR report key: 4841745 · Received June 12, 2015

    Report

    Report Number
    0002249697-2015-01905
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    March 13, 2014
    Report Date
    May 14, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED DEVICE INVOLVING AN EXETER BONE PLUG WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS WAS PERFORMED ON THE RETURNED SEGMENT OF THE BONE PLUG AND INDICATED THAT THE BONE PLUGS OF BOTH INTRODUCERS FAILED IN OVERLOAD. THE EXACT LOCATION OF THE FRACTURE ORIGIN FOR EACH OF THE SURFACES WAS NOT POSSIBLE TO BE DETERMINED DUE TO POST-FRACTURE DEGRADATION OF THE POLYMER MATERIAL. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN TWO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: BASED ON MATERIAL ANALYSIS THAT WAS PERFORMED ON THE RETURNED SEGMENT OF THE BONE PLUG, IT WAS INDICATED THAT THE BONE PLUGS OF BOTH INTRODUCERS FAILED IN OVERLOAD. THE EXACT LOCATION OF THE FRACTURE ORIGIN FOR EACH OF THE SURFACES WAS NOT POSSIBLE TO BE DETERMINED DUE POST-FRACTURE DEGRADATION OF THE POLYMER MATERIAL. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED THAT FRACTURE OF EXETER BONE PLUGS MAY RESULT FROM FACTORS SUCH AS ERRORS MADE DURING USE OR DESIGN FACTORS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS THE DEVICE WAS NOT RECEIVED BY STRYKER ORTHOPAEDICS. IF THE DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    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 THE SURGERY THAT TOOK PLACE ON (B)(6) 2015 ONE BONE PLUGS BROKE, CODE 09390114, LOT L7396.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THAT TOOK PLACE ON (B)(6) 2015 ONE BONE PLUGS BROKE, CODE 09390114, LOT L7396.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386484 EXETER 2.5 I M PLUG 14MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH L7396

    Patients

    Seq Age Sex Outcome Treatment
    1 Other