BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.3MM PERCUTANEOUS THREADED DRILL GUIDE

    MDR report key: 3010781 · Received March 19, 2013

    Report

    Report Number
    8030965-2013-10520
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    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. 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. PRODUCT DEVELOPMENT REPORTS THE SAMPLE WAS RECEIVED WITH SOME DISCOLORATION AROUND THE ETCH ON THE SHAFT AND TOP OF THE HEAD. MINOR SCRATCHES LOCATED ON THE DEVICE ARE CONSISTENT WITH FIELD USAGE. THE THREADS, BOTH EXTERNAL ON THE END THAT ENGAGES THE PLATE AND INTERNAL THAT ACCEPT THE HANDLE, WERE INTACT AND SUCCESSFULLY ASSEMBLED WITH THE MATING PARTS. NO DAMAGE VISIBLE ON THE THREADS. THE RETURNED PART DOES NOT EXHIBIT THE COMPLAINT CONDITION AND WAS SUCCESSFULLY ASSEMBLED WITH THE MATING PARTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE.

    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) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE INTERNAL THREADS ON THE DRILL GUIDE STRIPPED, AND WOULD NOT ENGAGE THE THREADS. THIS WAS DISCOVERED WHILE STILL ON THE BACK TABLE. NO PATIENT CONTACT REPORTED. SURGEON USED ANOTHER DRILL GUIDE FROM ANOTHER SET TO COMPLETE THE PROCEDURE.

    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
    114093 4.3MM PERCUTANEOUS THREADED DRILL GUIDE FZX SYNTHES GMBH 1989224

    Patients

    Seq Age Sex Outcome Treatment
    1