BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM UNIVERSAL VARIABLE ANGLELOCKING DRILL GUIDE

    MDR report key: 3070560 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10893
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    September 27, 2011
    Report Date
    September 27, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED WITHOUT VISIBLE DAMAGES. THE MEASURABLE DIMENSIONS ARE WITHIN PRINT SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS, A REVIEW OF THE PRODUCT DRAWINGS SHOWED THAT BOTH ENDS OF THE DRILL GUIDE WERE DESIGNED WITH THE CORRECT TOLERANCES TO ALLOW FOR SEATING INTO THE 2.4MM VA LOCKING HOLES. THEY ARE MANUFACTURED OUT OF AN APPROPRIATE MATERIAL FOR A DRILL GUIDE. THE DRILL GUIDES ARE (B)(4), WHICH WOULD NOT ADD TO THE FAILURE. SINCE THE DRILL GUIDE SEATED WITH NO PROBLEMS INTO SEVERAL PLATES HERE DURING TESTING IT IS DETERMINED THERE WAS EITHER A PROBLEM WITH THE PLATE HOLES OR USER ERROR. THEREFORE THIS COMPLAINT IS DEEMED INVALID.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF DISTAL RADIUS, THE SURGEON COMPLAINED THAT THE DRILL GUIDE WILL NOT KEY IN OR LOCK INTO THE PLATE AS INTENDED. THE SURGEON COMPLETED THE PROCEDURE FREE-HAND, WITHOUT THE DRILL GUIDE. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170977 1.8MM UNIVERSAL VARIABLE ANGLELOCKING DRILL GUIDE FZX SYNTHES GMBH 2513563

    Patients

    Seq Age Sex Outcome Treatment
    1