BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 4300263 · Received December 5, 2014

    Report

    Report Number
    3003875359-2014-10408
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 1-AUG-2014. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    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 RETURNED TO THE MANUFACTURING FACILITY FOR REVIEW ON NOVEMBER 21, 2014. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE PRONGS INSIDE THE CHUCK BROKE OFF. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE EVALUATION WAS CONFIRMED. PRODUCT EVALUATION: THE 393.105, LOT 8982843 SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS RECEIVED INTACT. THE DEVICE APPEARS TO BE IN VERY GOOD CONDITION; HOWEVER, TWO OF THE THREE DISTAL CLAMPING PRONGS ARE MISSING FROM THE DEVICE. THE DEVICE IS AN INSTRUMENT ROUTINELY USED IN NUMEROUS PROCEDURES AND TECHNIQUE GUIDES FOR THE MANUAL INSERTION OF KIRSCHNER WIRES, SCHANZ SCREWS AND STEINMANN PINS. THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS RETURNED AND REPORTED TO HAVE HAD TWO PRONGS FROM THE DISTAL CLAMPING PORTION OF THE DEVICE BROKEN OFF. THIS CONDITION IS CONFIRMED; TWO OF THE THREE DISTAL CLAMPING PRONGS ARE MISSING FROM THE DEVICE DESPITE OTHERWISE BEING IN VERY GOOD CONDITION. IT IS LIKELY THAT THE DEVICE WAS TWISTED OR BENT WHILE CLAMPED ONTO A GUIDE WIRE. THIS WOULD HAVE INTRODUCED THE SHEAR FORCES NECESSARY TO SEPARATE THE TWO PRONGS FROM THE DEVICE. (B)(4) WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. IT IS LIKELY THAT THE INTRODUCTION OF SHEAR FORCES BY IMPROPERLY BENDING OR TWISTING THE DEVICE LED TO THIS CONFIRMED COMPLAINT; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED TWO PRONGS BROKE OFF OF THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WHEN GRIPPING ONTO WIRE. THIS EVENT OCCURED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WILL BE MADE AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788146 SMALL UNIVERSAL CHUCK WITH T-HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8982843

    Patients

    Seq Age Sex Outcome Treatment
    1