BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINLOCK II CANNULA SCREWDRIVER FOR 3.5MM HEX

    MDR report key: 1361063 · Received January 14, 2009

    Report

    Report Number
    1220246-2008-00269
    Event Type
    Other
    Date Received
    January 14, 2009
    Date of Event
    December 3, 2008
    Report Date
    December 17, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE MOST LIKELY CAUSES OF TIP BREAKAGE ARE FLEXING THE JOINT DURING INSERTION OF THE IMPLANT WITH THE DRIVER ENGAGED, PRYING/LEVERAGING THE DRIVER (SCREW DOES NOT SEAT FULLY ON DRIVER) WHILE THE IMPLANT IS STILL LOADED, CONTINUALLY APPLYING TORQUE AFTER THE SCREW IS FULLY SEATED, TORQUING WHEN THE IMPLANT IN NOT PROPERLY ALIGNED, TORQUING WHILE LEVERAGING THE DEVICE AND/OR USING THE INCORRECT SCREW WITH THE DRIVER (SCREW DOES NOT FULLY SEAT ON THE DRIVER). IN ADDITION, THE EXPECTED LIFE OF THIS DEVICE HAS BEEN EXCEEDED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING REVEALED TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE THE SURGEON WAS LOOSENING/REMOVING A SCREW. THIS OCCURRED DURING A SURGERY ON (B) (6) 2008. THE DRIVER TIP WAS NOT RETRIEVED; IT WAS RETAINED IN THE PT. THE CASE WAS COMPLETED. ONE WEEK LATER (ON (B) (6) 2008), THE PT WAS UNDERGOING ANOTHER PROCEDURE (AN OPENING WEDGE HIGH TIBIAL OSTEOTOMY). DUE TO THE SURGICAL OPPORTUNITY, THE DRIVER TIP WAS RETRIEVED AT THAT TIME. THE PT WAS REPORTED AS DOING WELL; THERE WAS NO PT INJURY. NO FURTHER PT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR IN FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINLOCK II CANNULA SCREWDRIVER FOR 3.5MM HEX LXH ARTHREX, INC. NA 17962908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED.