BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY/STEM SEPARATOR

    MDR report key: 4100050 · Received September 18, 2014

    Report

    Report Number
    0002249697-2014-03550
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE DEVICE WAS RECEIVED AND WAS FOUND TO HAVE SCRATCHES THROUGHOUT THE SURFACE INDICATIVE OF HEAVY USE. THE ADAPTOR END OF THE DEVICE WAS DAMAGED INDICATIVE OF OVERTIGHTENING OF THE INSTRUMENT DURING USE BY THE SURGEON. THE TIP OF THE INSTRUMENT WHICH CONNECTS TO THE IMPLANT SHOWED DAMAGE NEAR IT'S BASE LIKELY DUE TO THE WAREHOUSE DISASSEMBLING THE IMPLANT FROM THE INSTRUMENT. DEVICE INSPECTION INDICATED THE INSTRUMENT WAS MISUSED AT IT WAS RECEIVED OVERTIGHTENED WHICH LIKELY CAUSED THE DIFFICULTY DISASSEMBLING THE ATTACHED IMPLANT. THE DAMAGED DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN IMPLANT WAS REMOVED USING AN INSTRUMENT CALLED A BODY STEM SEPARATOR. THIS REMOVES A PREVIOUSLY IMPLANTED CONE BODY. THE INSTRUMENT AND THE IMPLANT RETURNED TO THE (B)(4) WAREHOUSE ATTACHED TO EACH OTHER. WHILE CHECKING IN THE INSTRUMENT TRAY THE RECEIVING DEPARTMENT NOTICED THIS AND ATTEMPTED TO SEPARATE THE IMPLANT FROM THE INSTRUMENT. THEY WERE ABLE TO SEPARATE A PORTION OF THE INSTRUMENT BUT NOTICED THAT THE INSTRUMENT WAS TOO DAMAGED TO RETURN TO SURGERY.

    Description of Event or Problem · 1

    AN IMPLANT WAS REMOVED USING AN INSTRUMENT CALLED A BODY STEM SEPARATOR. THIS REMOVES A PREVIOUSLY IMPLANTED CONE BODY. THE INSTRUMENT AND THE IMPLANT RETURNED TO THE (B)(6) ATTACHED TO EACH OTHER. WHILE CHECKING IN THE INSTRUMENT TRAY THE RECEIVING DEPARTMENT NOTICED THIS AND ATTEMPTED TO SEPARATE THE IMPLANT FROM THE INSTRUMENT. THEY WERE ABLE TO SEPARATE A PORTION OF THE INSTRUMENT BUT NOTICED THAT THE INSTRUMENT WAS TOO DAMAGED TO RETURN TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578332 BODY/STEM SEPARATOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TACL400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other