BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA SCREWDRIVER, MODULAR

    MDR report key: 1901482 · Received October 16, 2009

    Report

    Report Number
    1649384-2009-00333
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 16, 2009
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND NOT IMPLANTABLE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PART MET SPECIFICATION. VISUAL EXAMINATION OF THE RETURNED INSTRUMENT INDICATES THE HEX MATING TIP IS CRACKED ON 3 ADJACENT ANGLES WITH MATERIAL BENT SLIGHTLY OUTWARD. THE REPORT INDICATES THE PA WAS USING THE DRIVER IN GOOD BONE WITHOUT EXCESSIVE FORCE WHEN THE DRIVER CRACKED. THE LIKELY CAUSE FOR THE INSTRUMENT TO CRACK ALONG 3 ADJACENT ANGLES IS OFF AXIS FORCE APPLIED TO THE DRIVER DURING USE. THE REDUNDANT INSTRUMENT PROVIDED IN THE KIT WAS USED TO COMPLETE THE SURGERY WITHOUT A DELAY.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON'S PHYSICIAN ASSISTANT (P.A.) DAMAGED THE SEQUOIA MODULAR SCREWDRIVER DURING SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE ON (B)(6) 2009: A PRIMARY FUSION SURGERY WAS PERFORMED ON THE PT ON (B)(6) 2009. THE P.A. WAS WORKING IN THE SACRAL AREA ON GOOD BONE NOT USING A GREAT DEAL OF FORCE WHEN THE SEQUOIA MODULAR DRIVER CRACKED. NO PIECES CAME OFF OF THE DRIVER. THERE WAS NO SURGICAL DELAY, AND THE SALES REPRESENTATIVE HAD ANOTHER OF THE SAME DRIVER THAT WAS UTILIZED TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA SCREWDRIVER, MODULAR SEQUOIA NKB ZIMMER SPINE 54MR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK