BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 4221194 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14442
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: UNKNOWN, BUT HAS TO BE PRIOR TO AUGUST 1987. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE T-HANDLE WAS CRACKED. THE REPAIR TECHNICIAN REPORTED THE CHUCK WAS VERY BEAT UP, AND THE RATCHET WAS LOUD AND STICKING. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: BOTH UNIVERSAL CHUCKS WERE REPORTED AS PART NUMBER 393.10 BUT IT HAS BEEN DETERMINED THAT ONE IS PART NUMBER 393.19. THIS EVALUATION IS FOCUSED ON PART NUMBER 393.19. THE DATE OF MANUFACTURE IS UNKNOWN FOR THE RETURNED UNIVERSAL CHUCK (PART NUMBER 393.19, LOT NUMBER UNKNOWN). IT WAS RECEIVED PARTIALLY DISASSEMBLED. THE SET SCREW WAS REMOVED FROM THE ASSEMBLY AND THE RATCHETING COMPONENTS ARE NO LONGER SECURED IN PLACE BUT ARE RETAINED ON THE SHAFT. THERE ARE DENTS OVER THE LENGTH OF THE DEVICE AND A CONCENTRATED AREA OF DENTS ON THE MIDDLE OF THE CHUCK WHICH LIKELY RESULTED IN THE DISASSEMBLED RATCHETING MECHANISM. THERE ARE ALSO SIGNIFICANT IMPACT MARKS ON THE CENTER OF THE DISTAL END. THE T- HANDLE APPEARS TO HAVE BEEN POLISHED DOWN AND THE CONNECTION SHOWS A CRACK AND POSSIBLE EVIDENCE OF BEING REWORKED. THE CHUCK DOES OPEN AND CLOSE, HOWEVER THE RATCHETING MECHANISM DOES NOT FUNCTION AS IT IS DISASSEMBLED. THE UNIVERSAL CHUCK WITH AN UNKNOWN LOT NUMBER IS ETCHED AS PART NUMBER 393.19. WHILE THE MANUFACTURE DATE IS UNKNOWN, THIS DEVICE WAS OBSOLETE IN AUGUST 1987 AND REPLACED WITH THE 393.10. THEREFORE, THE RETURNED DEVICE IS AT LEAST 27 YEARS OLD. A REVIEW OF THE CURRENT EDITION OF THE 393.10 DESIGN DRAWING, WAS PERFORMED TO ENSURE THE REPLACEMENT DEVICE IS ADEQUATE. THESE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE. THE COMPLAINT CONDITION IS CONSISTENT WITH EXCESSIVE HAMMERING ON THE DEVICE OVER ITS EXTENDED LIFETIME AND SHOWS EVIDENCE OF THE T-HANDLE HAVING BEEN REWORKED. THE DEVICE IS NOT INTENDED TO WITHSTAND HAMMERING, THUS, THE METHOD OF USE RESULTED IN THE COMPLAINT CONDITION. IN CONCLUSION, THE COMPLAINT CONDITION IS CONFIRMED. THE CURRENT DESIGNS FOR THE REPLACEMENT DEVICE WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE AND BASED ON THE RETURNED CONDITION THE ROOT CAUSE WAS DETERMINED TO BE FROM EXCESSIVE FORCE ON THE DEVICE DURING OVER 27 YEARS OF USE. THE RISK ANALYSIS ADEQUATELY ADDRESSES 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 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. SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 UNIVERSAL CHUCK WITH T-HANDLE THE ¿T¿ PART OF THE T-HANDLE IS CRACKED. ON ANOTHER UNIVERSAL CHUCK WITH T-HANDLE THE CHUCK IS STRIPPED. IT WAS DISCOVERED DURING SURGERY, BUT HAD NO NEGATIVE OUTCOME TO THE SURGERY OR PATIENT. IT WAS REPORTED THERE WAS A DELAY IN THE PROCEDURE OF GREATER THAN FOURTEEN MINUTES, BUT LESS THAN THIRTY MINUTES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702560 UNIVERSAL CHUCK WITH T-HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1