BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM

    MDR report key: 4325037 · Received December 12, 2014

    Report

    Report Number
    0009610622-2014-00675
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATED THE DRILL, TRI-FLAT T2 FEMUR TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT AS THE DEVICE WAS NOT RETURNED TO STRYKER (B)(4). MOREOVER, A REVIEW OF THE DEVICE HISTORY COULD NOT BE CARRIED OUT AS THE LOT CODE WAS UNKNOWN. THUS, A REASONABLE EXAMINATION WAS NOT POSSIBLE. ACCORDING TO INFORMATION RECEIVED THE DEVICE WAS DISCARDED BY THE CUSTOMER. THE REPORTED EVENT (¿TIP OF DRILL HAS BROKEN ¿) COULD THEREFORE NOT BE CONFIRMED. THE EVENT DESCRIPTION STATED THAT THE DRILL HAD CONTACT TO THE NAIL, WHILE DRILLING THE DISTAL SCREW HOLE WHICH HAD LED TO THE BREAKAGE OF THE DRILL. BASED ON THE INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO AN IMPROPER HANDLING BY THE USER. NEVERTHELESS AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE FILE WILL BE CLOSED FORMALLY IN ACCORDANCE TO OUR PROCEDURES. IN CASE THE ITEM AND / OR SUBSTANTIVE INFORMATION WILL BECOME AVAILABLE IN FUTURE THE FILE WILL BE REVIEWED AND REOPENED. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT HAD A TKA ON (B)(6) 2014. THE PATIENT THAN HAD A T2 SCN FOR A SUPRACONDYLAR FEMUR FRACTURE. DURING T2 SCN SURGERY, THE SURGEON DRILLED THE DISTAL SCREW HOLE. HOWEVER, THE DRILL BIT CONTACTED THE NAIL AND THE TIP OF DRILL BROKE. THE SURGEON REMOVED THE BROKEN DRILL TIP FROM PATIENT BONE.

    Description of Event or Problem · 1

    THE PATIENT HAD A TKA ON (B)(6) 2014. THE PATIENT THAN HAD A T2 SCN FOR A SUPRACONDYLAR FEMUR FRACTURE. DURING T2 SCN SURGERY, THE SURGEON DRILLED THE DISTAL SCREW HOLE. HOWEVER, THE DRILL BIT CONTACTED THE NAIL AND THE TIP OF DRILL BROKE. THE SURGEON REMOVED THE BROKEN DRILL TIP FROM PATIENT BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809497 DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS HWE STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other