BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    MDR report key: 3072443 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-11065
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THERE ARE NO VISIBLE DAMAGES. THE DIMENSIONS AT THE RUN-IN AND RUN-OUT DIAMETERS OF THE THREAD MEET THE SPECIFICATIONS REFERRING TO DRAWING (B)(4). THE DEVICES PASSED THE FUNCTIONAL TEST ON A NEW PLATE SUCCESSFULLY; THE FAULT AS PER COMPLAINT DESCRIPTION COULD NOT BE DUPLICATED. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    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 DURING A 1, 2, 3, METATARSAL FRACTURE REPAIR, AS THE SURGEON WAS USING THE DRILL GUIDES, THEY WOULD NOT THREAD INTO LOCK INTO THE PLATE. THE BENDING PIN THREADED, HOWEVER, THE DRILL GUIDE WOULD NOT. THE SURGEON COMPLETED THE SURGERY WITHOUT THE DRILL GUIDE, WITHOUT FURTHER INCIDENT AND WITH NO ADVERSE EFFECT TO PATIENT NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR THE TWO DRILL GUIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174284 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE FZX SYNTHES GMBH 3338682

    Patients

    Seq Age Sex Outcome Treatment
    1