BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING ATTACHMENT 1.2NM

    MDR report key: 3963107 · Received July 29, 2014

    Report

    Report Number
    3009450871-2014-10296
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    LXH
    PMA / PMN Number
    PK072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: ODP. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOCKING SCREW STRIPPED AND A TORQUE LIMITER BROKE DURING SURGERY. THE SURGEON WAS PERFORMING A TOTAL ANKLE FUSION PROCEDURE AND AS THE SURGEON PLACED THE PLATE, DRILLED TO PUT THE SCREW INTO THE TAYLOR NAVICULAR JOINT WITH THE TORQUE LIMITER, THE LIMITER ENGAGED THE SCREW AND THE SCREW WENT THROUGH THE PLATE. THE TORQUE LIMITER THEN ¿SNAPPED¿ OFF. IT WAS REPORTED THAT THE THREADS STRIPPED OFF OF THE SCREW. IT WAS REPORTED THAT THE SURGEON WAS PLACING THE SCREW INTO THE CENTER OF THE PLATE. THE SURGEON REMOVED THE PLATE, PLACED FOUR NEW SCREWS AND SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INFORMATION WAS AVAILABLE AT THE TIME OF THE CALL. THERE WAS A ONE MINUTE DELAY IN SURGERY. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440916 TORQUE LIMITING ATTACHMENT 1.2NM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES POWER TOOLS 7365

    Patients

    Seq Age Sex Outcome Treatment
    1