BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/TAP AND SCREW GUIDE WITH HANDLE

    MDR report key: 3081843 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11191
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    December 6, 2011
    Report Date
    December 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. ADDITIONAL INFORMATION WAS RECEIVED (B)(4) 2013. 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DUE TO THE DAMAGE AND THE MISSING PART THE MANUFACTURING EVALUATION DETERMINED THE RELEVANT DIMENSIONS CANNOT BE VERIFIED. THE VISUAL INSPECTION REVEALED THE FRACTURE FACE OF THE BROKEN FLANGE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE APPEARANCE OF THE REMAINING FLANGES THE INVESTIGATION DETERMINED THAT A MECHANICAL OVERLOAD DURING USE MAY HAVE CONTRIBUTED TO THIS EVENT, POSSIBLY BY APPLYING TOO MUCH LATERAL STRESS. THE PRODUCT EVALUATION DETERMINED THE INSTRUMENT DOES NOT SHOW SIGNS THAT THE DESIGN CONTRIBUTED TO THE ISSUE. BASED ON CUSTOMER FEEDBACK THE INSTRUMENT MAY HAVE EXPERIENCED SOME EXCESSIVE SIDE LOADS. IF THE TRAJECTORY OF THE SCREWS IS SET AT AN EXTREME, AS DESCRIBED, OR IF SOFT TISSUE WAS IN THE WAY THE FLANGES COULD FLEX TO THE POINT OF YIELD. THE CAUSE OF THE INCIDENT WAS MOST LIKELY THE RESULT OF AN EXCESSIVE FORCE ON THE DEVICE. THE COMPLAINT WILL THEREFORE BE CONSIDERED INVALID.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TO CONSULTANT: DURING AN ANTERIOR CERVICAL DECOMPRESSION FUSION PROCEDURE, THE SURGEON WAS USING DRILL/TAP AND SCREW GUIDE AND THE PRONGS OF THE GUIDE BENT AND SLIGHTLY BROKE. CONSULTANT REPORTED SURGEON WAS HARD ON THE ANGLE. PATIENT WAS NOT AFFECTED BY THE OUTCOME. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE REPORTED ISSUE WAS DISCOVERED PRIOR TO, NOT DURING, THE PROCEDURE. THE INSTRUMENT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183425 DRILL/TAP AND SCREW GUIDE WITH HANDLE FZX SYNTHES GMBH 1776408

    Patients

    Seq Age Sex Outcome Treatment
    1