BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 3063683 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10816
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION OBSERVED THAT ONE CLAMPING JAW HAS FALLEN OUT OF THE HOUSING AND WAS NOT SEND BACK FOR INVESTIGATION. ONE JAW HAS A DEFORMATION AT THE FOREFRONT AND A PIECE OF ONE CORNER WAS BROKEN OFF. THERE WERE DIFFERENT MARKS AND DENTS AT THE FOREFRONT OF THE HOUSING VISIBLE. BASED ON THE DAMAGE OF ONE OF THE REMAINING JAWS AND BECAUSE OF THE MARKS AT THE HOUSING IT CAN BE ASSUMED THAT INAPPROPRIATE AND EXCESSIVE HAMMER BLOWS ONTO THE CHUCK CAUSED THIS OCCURRENCE. WITHOUT THE MISSING JAW NO FINAL CONCLUSION FROM A MANUFACTURING STANDPOINT IS POSSIBLE. THEREFORE THIS COMPLAINT IS INDETERMINATE. PRODUCT DEVELOPMENT EVALUATION STATED THAT ONE OF THE 3 MOVING JAW PARTS WAS FRACTURED BELOW THE SHELL OF THE INSTRUMENT AND WAS NOT RECEIVED. ANOTHER JAW IS SLIGHTLY CHIPPED AND THE HOUSING OF THE INSTRUMENT HAS MANY SMALL MARKS AND DENTS NEAR THE TIP. THE DESIGN WAS EVALUATED AND FOUND SUFFICIENT. IT APPEARS THAT THIS INSTRUMENT WAS USED FOR AN UNINTENDED PURPOSE. THE MARKS AND DENTS ON THE TIP OF THE HOUSING SUGGEST THAT THE INSTRUMENT WAS HIT WITH SOME OTHER HARD OBJECT REPEATEDLY. THE INSTRUMENT IS NOT INTENDED TO BE STRUCK OR IMPACTED IN ANY WAY AND IS NOT ADVERTISED AS BEING USEFUL FOR THIS PURPOSE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A HUMERAL NAIL PROCEDURE, SMALL UNIVERSAL CHUCK WITH T-HANDLE (393.105) BROKE WHERE THE INNER NOSEPIECE AND THE HOUSING COME TOGETHER, WHILE THE SURGEON WAS TRYING TO CRIMP A BALL-TIP GUIDE WIRE. BOTH PIECES OF THE T-HANDLE WERE RETRIEVED AND REMOVED FROM THE OR. A SECOND T-HANDLE CHUCK WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166233 SMALL UNIVERSAL CHUCK WITH T-HANDLE LXH SYNTHES GMBH 3288640

    Patients

    Seq Age Sex Outcome Treatment
    1