BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE OSTEOTOME STRAIGHT

    MDR report key: 2193197 · Received July 21, 2011

    Report

    Report Number
    9617544-2011-00255
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 27, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, MFG RECORD REV. RISK ASSESSMENT AND VISUAL INSPECTION. RESULTS: COMPLAINT HISTORY ANALYSIS, 25 PREVIOUS COMPLAINTS ON THE OSTEOTOME STRAIGHT AND CURVED CHISELS, WHICH ARE OF SIMILAR DESIGN. MOST OF THE REPORTS INVOLVED BEING DAMAGE AT THE TIP. A CAPA HAS BEEN OPENED IN RESPONSE TO THESE REPORTS. MFG RECORD REV., NO DISCREPANCIES FOUND THAT COULD BE RELATED TO THIS ISSUE. RISK ASSESSMENT, A FORMAL HEALTH RISK ASSESSMENT IS CURRENTLY BEING CONDUCTED AS PART OF THE OPENED CAPA, NO ADVERSE CONSEQUENCES TO THE PATIENT IN THIS EVENT. VISUAL INSPECTION, TIP CONFIRMED CHIPPED, DULL, BLUNT AND BENT. SCUFF MARKS ON THE BLADE INDICATE WEAR AND TEAR FROM MULTIPLE USES. CONCLUSION: THE INSTRUMENT IS DESIGNED WITH A THIN SHARP EDGE TO REMOVE BONE TO GAIN ACCESS TO THE DISC SPACE. THE NATURE OF THE INTERACTION BETWEEN A SHARP TIP AND HARD BONE HAS CREATED A PROPENSITY OF TIP FRACTURES IN THESE INSTRUMENTS. A CAPA HAS BEEN OPENED GIVEN THE TREND OF TIP FRACTURES WITH BOTH THE STRAIGHT AND CURVED OSTEOTOMES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SURGEON WAS USING STRAIGHT CHISEL TO PERFORM FACETECTOMY AT THE 64-5 LEVEL AND NOTICED THAT THE TIP OF THE CHISEL HAD "CHIPPED" OFF. HE RETRIEVED A SMALL PIECE OF METAL FROM THE BO(XX) OF THE FALET. HE THEN PROCEEDED TO COMPLETE THE FACETECTOMY USING THE CURVED CHISEL AND AGAIN NOTICED THAT THE END OF THE CHISEL HAD CHIPPED OFF AS WELL. HE COMPLETED THE FACETECTOMY WITH A CHISEL FROM ANOTHER VENDOR AND COMPLETED THE SURGERY WITHOUT FURTHER INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE OSTEOTOME STRAIGHT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 10E719

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR