BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE SLEEVE 10.5X268MM

    MDR report key: 2317834 · Received October 14, 2011

    Report

    Report Number
    9610622-2011-00517
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 23, 2011
    Report Date
    September 23, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME IT IS NOT KNOWN IF THE DEVICES WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES ARE: 1320-0100, KME 901974, TARGET DEVICE. 1320-0117, KH1083220, TARGET SLEEVE. 1320-0105, KH1071125, KNOB F. TARGET DEVICE. 1320-0130, K575281, LAG SCREW GUIDE SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE DOCTOR COMPLAINED THAT THE K-WIRE USED TO DIRECT THE LAG SCREW REAMING WOULD NOT CENTER INSIDE OF THE NAIL. THE DOCTOR STATED THAT THE ISSUE HAS HAPPENED SEVERAL TIMES AND THAT HE WAS NOT HAPPY WITH HOW THE PROBLEM WAS BEING ADDRESSED. BEFORE IMPLANTING THE NAIL, THE ONE STEP REAMER WAS USED. SUBSEQUENTLY THE NAIL WOULD NOT SEAT TO THE PROPER DEPTH. THE NAIL WAS REMOVED AND FLEXIBLY REAMED TO 12MM DISTALLY AND 15.5 PROXIMALLY TO LESSER TROCHANTER. THE NAIL WAS INSERTED TO PROPER DEPTH AND K-WIRE SLEEVE WAS INSERTED. K-WIRE WAS INSERTED AND KEPT RIDING SUPERIORLY ON THE EDGE INSIDE THE NAIL. THE DOCTOR USED A DRILL TO PERFORATE CORTEX THEN USED LAG REAMER AS WELL TO PERFORATE CORTEX. THE NAIL WAS FINALLY IMPLANTED. THE DOCTOR WOULD LIKE THE TARGETING ARM EXCHANGED OR A RESOLUTION TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE SLEEVE 10.5X268MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K540393

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other