BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXANO IO-FLEX MICROBLADE SHAVER

    MDR report key: 2222861 · Received July 10, 2011

    Report

    Report Number
    3006324586-2011-00011
    Event Type
    Other
    Date Received
    July 10, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF PRODUCT INVESTIGATION. A BAXANO IO-FLEX MICROBLADE SHAVER 7.5MM DEVICE (LOT 11031804) WAS RETURNED (RMA (B)(4)) FOR INVESTIGATION UNDER COMPLAINT (B)(4). IT WAS STATED THAT AFTER TREATMENT OF THE 2ND FORAMEN, THE MICROBLADE SHAVER DEVICE COULD NOT BE REMOVED. THE SURGEON TRIED TO DISLODGE THE DEVICE USING A BALL PROBE WITH NO SUCCESS. WITH CONTINUED ATTEMPTS TO REMOVE THE DEVICE, EVENTUALLY THE DEVICE BROKE AND THE SURGEON HAD TO REMOVE ALL OF THE COMPONENTS SEPARATELY. UPON REMOVAL OF THE GELPI RETRACTOR, THE REMAINING SECTION OF THE MICROBLADE SHAVER DEVICE WAS ABLE TO BE REMOVED EASILY. IT WAS CONCLUDED THAT THE MBS DEVICE HAD BECOME CAUGHT IN THE GELPI RETRACTOR. A RADIOLOGIC IMAGE WAS TAKEN TO DETERMINE RETRIEVAL WAS COMPLETE. INVESTIGATION FINDINGS: INSPECTION OF THE RETURNED DEVICE NOTED THE CABLE SHOWED SIGNS OF CRUSHING AND FATIGUE DAMAGE BETWEEN CUTTING SEGMENTS, CONSISTENT WITH AGGRESSIVELY PULLED UPWARD AND SIDE TO SIDE. IN ADDITION, THE DISTAL SECTION OF THE DEVICE HAD SIGNS OF TOOLING MARKS ON THE DORSAL SIDE OF THE DEVICE, WHICH IS CONSISTENT WITH RUBBING ONTO AND HOOKING ONTO THE GELPI SURGICAL RETRACTOR. THE PRODUCT INVESTIGATION CONCLUDED THAT THE PROBABLE ROOT CAUSE WAS THE DEVICE HOOKED ONTO THE GELPI RETRACTOR AND THE TENSILE STRENGTH OF THE DEVICE WAS EXCEEDED WHEN TRYING TO REMOVE THE DEVICE. THE SURGEON WAS CONTACTED FOR PT STATUS AT 2-WEEKS POST-OP AND IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS.

    Description of Event or Problem · 1

    THE SURGEON HAD DIFFICULTY REMOVING THE BAXANO MICROBLADE SHAVER DEVICE AFTER TREATMENT OF THE 2ND FORAMEN (L3/4). THE PHYSICIAN TRIED PULLING THE DEVICE AND ALSO USED A BALL PROBE WITH NO SUCCESS. EVENTUALLY, THE DEVICE BROKE. THE SURGEON USED A NEEDLE NOSE PLIER AND RONGEUR TO RETRIEVE COMPONENTS OF THE MICROBLADE SHAVER DEVICE AFTER THE DEVICE BROKE. AFTER HE HAD RETRIEVED THE COMPONENTS, HE USED THE DRILL TO OPEN MORE SPACE AND EXPLORE WHAT THE MICROBLADE SHAVER DEVICE WAS HOOKED ON. HE CONCLUDED THAT THE MICROBLADE SHAVER DEVICE HAD BECOME CAUGHT IN THE GELPI RETRACTOR (USED TO MAINTAIN VISUALIZATION WITHIN THE TARGET SITE BY RETRACTING TISSUE). UPON REMOVAL OF THE GELPI RETRACTOR, THE REMAINING SECTION OF THE DEVICE WAS ABLE TO BE REMOVED EASILY AND THERE WERE NO COMPONENTS REMAINING IN THE PT AS VERIFIED BY INTRAOPERATIVE RADIOLOGIC IMAGING. THE SURGEON PROCEEDED TO DECOMPRESS A 3RD FORAMEN WITH A NEW MICROBLADE SHAVER DEVICE. THE SURGEON WAS CONTACTED FOR PT STATUS AT 2-WEEKS POST-OP AND IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXANO IO-FLEX MICROBLADE SHAVER RONGEUR, MANUAL HAE BAXANO, INC. IO-MBS7.5SC 11031804

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention