BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2020710 · Received March 16, 2011

    Report

    Report Number
    1030489-2011-00287
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED CANNULA BROKEN ABOUT 35MM FROM TIP. VISUAL AND OPTICAL EXAMINATION IDENTIFIES PLASTIC DEFORMATION CONSISTENT WITH BEND STRESS OVERLOAD. THE NATURE AND LOCATION OF THE BREAKAGE IS CONSISTENT WITH OFF-AXIS MISALIGNMENT OF THE CANNULA DURING REMOVAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGERY WAS EXTENDED SEVERAL HOURS TO RECOVER THE BROKEN FRAGMENTS. IT IS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SEVERE BURNING PAIN AND NUMBNESS IN HER RIGHT LEG DUE TO LATERAL FEMORAL CUTANEOUS NEUROPATHY CAUSED BY EXCESSIVE COMPRESSION DURING THE SURGERY. IT IS ALLEGED THAT THE PATIENT COMPLICATIONS WERE DUE TO SURGICAL POSITIONING DURING THE EXTENDED TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE PERCUTANEOUS SURGICAL PROCEDURE AT L4. IT WAS REPORTED THAT THE NEEDLE BROKE OFF INSIDE THE PATIENTS PEDICLE AS IT WAS BEING PULLED OUT. THE SURGERY WAS EXTENDED 30 MINUTES WHILE THE BROKEN PIECE WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA 0131827W

    Patients

    Seq Age Sex Outcome Treatment
    1