BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 3072429 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-10961
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CHUCK WAS WORKING AS DESIGNED UNTIL THE SURGEON USED A MALLET TO TRY AND REMOVE THE REAMING ROD. THE CHUCK IS NOT DESIGNED TO BE IMPACTED IN SUCH A WAY AND THEREFORE THE CONDITION NOTED WAS NOT CAUSED BY A DESIGN ISSUE. THE DESIGN IS ACCEPTABLE AND THE COMPLAINT IS INVALID. PRODUCT DEVELOPMENT DETERMINED FURTHER INVESTIGATION WAS NOT NECESSARY BECAUSE THE DESIGN WAS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL NARRATIVE: THE PART/ LOT NUMBER COMBINATION PROVIDED COULD NOT BE VERIFIED. THE ORIGINAL IMPLANT DATE OF THE ROD WAS REPORTED TO BE (B)(6) 2011 AND THE EXPLANT OF THE BROKEN ROD WAS REPORTED TO BE (B)(6) 2011. (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHUCK WAS BROKEN TRYING TO REMOVE A BROKEN ROD AND WAS OUTSIDE THE PATIENT. THERE WAS NO IMPACT ON THE PATIENT DUE TO THE BROKEN CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE CHUCK WAS BROKEN WHEN THE SURGEON USED THE CHUCK TO REMOVE A DEPUY FEMORAL SUBTROCHANTERIC ROD WHICH WAS FOUND TO BE BROKEN. DEPUY HAS NO INSTRUMENTS TO REMOVE THE BROKEN ROD. IN ORDER TO REMOVE THE ROD, THE SURGEON TIGHTENED THE CHUCK ON THE GUIDE WIRE. HE THEN USED VISE GRIPS TO GRAB THE WIRE IN FRONT OF THE CHUCK. THE CHUCK WAS BEING USED TO KEEP THE VISE GRIPS FROM SLIDING. THE SURGEON USED A MALLET TO BANG ON THE VISE GRIPS, AND THEN THE CHUCK STOPPED WORKING, AND COULD NOT BE OPENED OR CLOSED. THE SURGEON WAS ABLE TO USE A SECOND VISE GRIP IN PLACE OF THE CHUCK TO COMPLETE THE PROCEDURE. WHEN THE ROD WAS REMOVED, CONSULTANT REPORTED THERE WAS NON-UNION OF THE FEMORAL FRACTURE WITH THE DEPUY PRODUCT; PATIENT WAS REVISED TO A 15MM X 400MM SYNTHES LATERAL ENTRY NAIL. THERE WAS NO REPORTED DELAY TO THE SURGERY AND NO EFFECT ON THE PATIENT STATUS OR OUTCOME WAS NOTED IN THE EVENT DETAILS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173762 SMALL UNIVERSAL CHUCK WITH T-HANDLE LXH SYNTHES GMBH 8017561

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR