BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL AND SCREW GUIDE

    MDR report key: 5429466 · Received February 10, 2016

    Report

    Report Number
    0008010177-2016-00019
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 13, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT SCREWDRIVER BLADE, CANNULATED WAS ALLEGED OF ISSUE BREAKAGE DURING SURGERY COULD BE CONFIRMED. THE VISUAL INSPECTION SHOWS THAT THE TIP OF THE SCREWDRIVER IS BROKEN DUE TO A TORSIONAL OVERLOAD. THE INSTRUMENT ALSO SHOWS SIGNS OF DISCOLORATION AND CORROSION WHICH ARE LIKELY INVOLVED WITH THE BREAKAGE. BASED ON THE INVESTIGATION RESULT THE ROOT CAUSE WOULD LIKELY BE RELATED WITH A USER RELATED ISSUE. THE INSTRUCTION FOR USE (90-01929 REV C 01-2014 TWIN FIX INSTRUMENTS IFU) WAS REVIEWED: ''THE PRODUCT MUST BE IMPLANTED IN THE CORRECT ANATOMICAL POSITION CONSISTENT WITH ACCEPTED STANDARDS FOR INTERNAL FIXATION. CARE MUST BE TAKEN TO ENSURE THAT THE SCREWDRIVER AND SCREW IMPLANT ARE ALWAYS IN AXIAL ALIGNMENT WITH EACH OTHER IN ORDER TO AVOID ANY MECHANICAL DAMAGE. THIS AXIAL ALIGNMENT CAN BE ACHIEVED USING THE TARGET DEVICE 07-40210 OR THE DRILL AND SCREW GUIDE 70-40250. IT IS EQUALLY IMPORTANT TO ENSURE THE CORRECT CONNECTION BETWEEN IMPLANT AND INSTRUMENT BY EXERTING SUFFICIENT AXIAL PRESSURE ON THE SCREWDRIVER BLADE SO AS TO PREVENT POTENTIAL MECHANICAL DAMAGE TO THE IMPLANT OR SCREWDRIVER BLADE. THE USER MUST BE FAMILIAR WITH THE INSTRUMENTS PRIOR TO USE AND SHOULD HAVE CHECKED TO ENSURE THAT BOTH THE IMPLANT AND INSTRUMENTS USED ARE INTACT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON, THE TIP OF THE SCREWDRIVER BROKE DURING SURGERY. PROCEDURE WAS INTERRUPTED. REPLACEMENT WAS ORDERED VIA EXPRESS SO THAT THE SURGERY COULD BE CONTINUED AND SUCCESSFULLY COMPLETED ON THE SAME DAY.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON, THE THE TIP OF THE SCREWDRIVER BROKE DURING SURGERY. PROCEDURE WAS INTERRUPTED. REPLACEMENT WAS ORDERED VIA EXPRESS SO THAT THE SURGERY COULD BE CONTINUED AND SUCCESSFULLY COMPLETED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85139 DRILL AND SCREW GUIDE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other