BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2181761 · Received July 27, 2011

    Report

    Report Number
    1030489-2011-00951
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED THE INSTRUMENT TIP IS BROKEN APPROXIMATELY 45MM FROM THE TIP. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE REVEALS A QUASI-BRITTLE ANGULATED FRACTURE WITH MATERIAL FLOW INDICATIVE OF TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO INFORMATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAVER WAS INSERTED INTO L4-L5 DISC SPACE. WHILE SHAVING, PADDLE TIP BROKE OFF INSIDE OF THE PATIENT. THE BROKEN PIECE WAS REMOVED USING LONG NEEDLE DRIVER. FLUOROSCOPY INDICATED THAT NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG DC09D020

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR