BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING ATTACHMENT 1.2NM

    MDR report key: 5466461 · Received February 29, 2016

    Report

    Report Number
    8030965-2016-11182
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 10, 2016
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: ONE (1) TORQUE LIMITING ATTACHMENT 1.2NM (PART 03.110.002 / LOT 1000904) WAS RECEIVED FOR EVALUATION WITH A COMPLAINT CATEGORY OF ¿BROKEN: INTRA-OPERATIVELY.¿ THIS COMPLAINT IS CONFIRMED, AS THE RETURNED DEVICE WAS RECEIVED IN FIVE (5) PIECES (SPRING, SCREW, NOSEPIECE, COUPLING, AND MAIN BODY). PER THE COMPLAINT DESCRIPTION, "THE SURGEON WAS RUNNING THE DRILL IN REVERSE TO BACK OUT A SCREW WHEN THE LIMITING ATTACHMENT BROKE." IT IS IMPORTANT TO NOTE THAT THIS DEVICE IS INTENDED TO LIMIT THE TRANSMISSION OF TORQUE DELIVERED DURING SCREW INSERTION AND IS NOT INTENDED TO BE USED FOR SCREW REMOVAL. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RELEVANT DRAWING FOR THE DEVICE WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED INSTRUMENT IS USED TO INSERT VARIABLE ANGLE LOCKING SCREWS IN PLATE IMPLANTATIONS AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN TECHNIQUE GUIDES. THE RETURNED DEVICE IS MULTIUSE AND IS USED FOR INSERTING THE DISTAL LOCKING SCREWS DURING IMPLANTATION. PER THE TECHNIQUE GUIDES, A TORQUE LIMITER MUST BE USED FOR FINAL TIGHTENING. THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY INATTENTIVENESS DURING STERILIZATION OR REMOVING A SCREW WITH THIS DEVICE UNDER POWER (PER THE COMPLAINT DESCRIPTION) WHEN ITS INTENDED USE IS TO LIMIT TORQUE DURING MANUAL SCREW INSERTION. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY INATTENTIVENESS DURING STERILIZATION OR REMOVING A SCREW WITH THIS DEVICE UNDER POWER. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. DEVICE 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

    ADDITIONAL NARRATIVE: PATIENT INITIALS ¿ (B)(6). PATIENT WEIGHT NOT AVAILABLE FOR REPORTING . ADDITIONAL PRODUCT CODE ¿ ODP. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW - MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 21. MAR. 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TORQUE LIMITING ATTACHMENT BROKE DURING A VARIABLE ANGLE PROCEDURE WITH A VARIABLE FIBULA PLATE. THE SURGEON WAS RUNNING THE DRILL IN REVERSE TO BACK OUT A SCREW WHEN THE LIMITING ATTACHMENT BROKE. THERE WAS NO FRAGMENT GENERATED. THE SURGEON DECIDED TO CONTINUE THE PROCEDURE WITHOUT THE INSTRUMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS AT THE END OF THE CASE WAS STABLE WITH NO ISSUES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125397 TORQUE LIMITING ATTACHMENT 1.2NM MISC ORTHO SURGICAL INSTR LXH SYNTHES OBERDORF 1000904

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR