BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 6333084 · Received February 15, 2017

    Report

    Report Number
    3006126083-2017-10008
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    SYNTHES RARON
    Product Code
    LXH
    UDI-DI
    10886982198983
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED FOR PART# 393.100, LOT# 3100186. A VISUAL INSPECTION, DEVICE HISTORY RECORDS REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THE T-HANDLE IS ENTIRELY BROKEN OFF THE DISTAL END OF THE DEVICE AT THE BASE OF CHUCK MECHANISM. IT IS LIKELY THAT OVER EIGHT YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 2/2009 AND IS OVER EIGHT YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY BATTERED CONDITION WITH MARKINGS FROM HAMMER STRIKES ALONG ITS LENGTH. THE 393.100 UNIVERSAL CHUCK WITH T-HANDLE IS AN INSTRUMENT ROUTINELY USED IN THE TFN ADVANCED PROXIMAL FEMORAL NAILING SYSTEM AS PER THE TECHNIQUE GUIDE. RELEVANT DRAWINGS WERE REVIEWED, AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE DATE: FEB 25, 2009. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 T-HANDLE CHUCK BROKE DURING A RIGHT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE ON (B)(6) 2017. THE T-HANDLE CHUCK BROKE INTO TWO PIECES AT THE POINT OF JUNCTURE OF THE CHUCK AND THE T-HANDLE WHILE THE SURGEON WAS EXTRACTING THE GUIDE WIRE. BOTH PIECES OF THE BROKEN T-HANDLE CHUCK WERE RETRIEVED EASILY WITH NO FRAGMENTS REMAINING. THE SURGEON WAS ABLE TO PULL THE WIRE OUT MANUALLY. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDE WIRE (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117309 UNIVERSAL CHUCK WITH T-HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES RARON 3100186 10886982198983

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNKNOWN GUIDE WIRE