BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 14MM

    MDR report key: 3012584 · Received March 20, 2013

    Report

    Report Number
    0002249697-2013-01041
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INTRAOPERATIVE FRACTURE INVOLVING A EXETER BONE PLUG WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: ¿THE EXETER PLUG FRACTURED IN OVERLOAD, LIKELY DUE TO THE FORCE REQUIRED TO SEAT THE DEVICE. FRACTURE INITIATED ALONG THE PROXIMAL EDGE AND PROPAGATED AXIALLY AROUND THE DEVICE. THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS ON THE DEVICE FEATURED EVALUATED.¿ DEVICE HISTORY REVIEW INDICATED THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT DEVICE FRACTURE WAS CAUSED BY USER MISUSE BY APPLYING TOO MUCH FORCE DURING IMPLANTATION.

    Description of Event or Problem · 1

    THE INTRAMEDULLARY PLUG WAS INSERTED INTO THE FEMORAL CANAL USING THE PROPER INSERTER AFTER THE CANAL HAD BEEN CORRECTLY SIZED USING THE EXETER SIZERS. THE PLUG SLOWED DOWN AROUND MID-CANAL BUT WITH GENTLE TAPS IT PASSED THROUGH TO THE DESIRED DEPTH. WHEN THE INSERTER WAS REMOVED THE TIP OF THE PLUG WAS FOUND STILL ATTACHED. IT WAS DECIDED NOT TO TRY AND RETRIEVE THE REMAINS OF THE IM PLUG, BUT INSTEAD TO PLACE A ON TOP.

    Description of Event or Problem · 1

    THE INTRAMEDULLARY PLUG WAS INSERTED INTO THE FEMORAL CANAL USING THE PROPER INSERTER AFTER THE CANAL HAD BEEN CORRECTLY SIZED USING THE EXETER SIZERS. THE PLUG SLOWED DOWN AROUND MID-CANAL BUT WITH GENTLE TAPS IT PASSED THROUGH TO THE DESIRED DEPTH. WHEN THE INSERTER WAS REMOVED THE TIP OF THE PLUG WAS FOUND STILL ATTACHED. IT WAS DECIDED NOT TO TRY AND RETRIEVE THE REMAINS OF THE IM PLUG, BUT INSTEAD TO PLACE A ON TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116012 EXETER 2.5 I M PLUG 14MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH L6102

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other