BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 5263511 · Received December 3, 2015

    Report

    Report Number
    1719045-2015-10785
    Event Type
    Injury
    Date Received
    December 3, 2015
    Date of Event
    November 6, 2015
    Report Date
    November 6, 2015
    Manufacturer
    SYNTHES RARON
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SERVICE HISTORY REVIEW: PART 393.105, LOT: 8002342: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. 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

    SERVICE HISTORY REVIEW: PART NO. 393.105, SERIAL/LOT NO: (B)(4): NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 24JULY2004. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE UNIVERSAL CHUCK T-HANDLE (393.10) AND THE SMALL UNIVERSAL CHUCK WITH T-HANDLE (393.105) INSTRUMENTS ARE EXTREMELY VERSATILE, MENTIONED IN MANY SYNTHES TECHNIQUE GUIDES. THEY ARE UTILIZED IN A LARGE NUMBER OF PROCEDURES INCLUDING KNEE, PELVIS, SCHANZ SCREW INSERTIONS, TIBIA, FEMUR, AND REMOVAL OF BROKEN NAILS. THERE ARE TWO OF THESE INSTRUMENTS IN MANY GRAPHIC CASES. THE RETURNED INSTRUMENTS WERE EXAMINED AND THE FINDS ARE AS FOLLOWS: 393.10 LOT 8805381 AND 393.105 LOT 4808768: THE RETURNED INSTRUMENTS WERE FOUND TO FUNCTION AS INTENDED. THE RATCHET MECHANISMS OPERATED SMOOTHLY. 393.10 LOT 9047945: THE HANDLE IS BENT AND UNTHREADING FROM THE CHUCK BODY. 393:10 LOT 4635193: THE RATCHET MECHANISM IS VERY ROUGH. THE INSTRUMENT STILL FUNCTIONS, BUT NOT SMOOTHLY. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THESE FAILURE MODES ARE TYPICALLY ASSOCIATED WITH WEAR AND TEAR/ROUGH HANDLING FOR MULTIUSE DEVICES. 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

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE T-HANDLE WAS UNABLE TO REMOVE THE SCREW. THE ITEM PASSED TESTING AND WORKED WITHIN NORMAL PARAMETERS. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. THE CAUSE OF THE COMPLAINED ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS 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.

    Additional Manufacturer Narrative · 1

    INITIALLY REPORTED AS (B)(6) 2015; SHOULD HAVE BEEN (B)(6) 2015. 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 THE PATIENT ORIGINALLY UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE TO TREAT A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE). THIS CONDITION WAS DUE TO A SHIFT IN THE PATIENT'S GROWTH PLATE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN AND A HIP SCOPE WAS PERFORMED. THE RESULTS OF THIS PROCEDURE INDICATED THE NEED FOR HARDWARE REMOVAL ON (B)(6) 2015. DURING THE REVISION SURGERY, ONE 7.3MM SCREW WAS DIFFICULT TO REMOVE FROM THE PROXIMAL FEMUR. THE SURGEON FIRST ATTEMPTED TO REMOVE THE SCREW WITH A T-HANDLE CHUCK BUT WAS UNSUCCESSFUL; THE T-HANDLE EITHER DISENGAGED OR BECAME DETACHED FOR THE BODY. THE FIRST T-HANDLE CHUCK WAS FITTED WITH THE CANNULATED SCREWDRIVER SHAFT AND TURNED IN REVERSE. THE SURGEON THEN ATTEMPTED REMOVAL WITH THREE (3) ADDITIONAL T-HANDLE CHUCKS WHICH ALSO DID NOT WORK AND LEFT THE SCREW STRIPPED. THE SURGEON OPTED TO USE A MIDAS REX HIGH SPEED DRILL TO REMOVE THE SCREW HEAD, LEAVING THE SCREW SHAFT IN THE PATIENT'S PROXIMAL FEMUR. THE COMPLAINED EVENT RESULTED IN A SURGICAL DELAY OF THIRTY TO FORTY-FIVE (30-45) MINUTES. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793358 SMALL UNIVERSAL CHUCK WITH T-HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES RARON 4808768

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention