BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 3070335 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10913
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND THE TIP OF THE AWL WAS BROKEN OFF AND WAS NOT SENT BACK FOR INVESTIGATION. THE SHAFT OF THE AWL WAS STRONGLY BENT AND HAMMER MARKS AT THE TOP OF THE HANDLE WERE VISIBLE. THE FRACTURE FACE WAS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. WITHOUT THE BROKEN FRAGMENT, THE RELEVANT DIMENSIONS COULD NOT BE CHECKED. THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. HOWEVER, BASED ON THE APPEARANCE, IT IS POSSIBLE THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO PERFORMED. THE AWL IS USED TO PREPARE THE HOLES FOR THE SCREW BY INSERTING THE AWL TIP INTO THE ZERO-P IMPLANT SCREW HOLE, AND THEN APPLYING AN AXIAL FORCE TO THE INSTRUMENT. THIS WAS VALIDATED IN LABS, WHICH DEMONSTRATED THAT THE DESIGN IS ACCEPTABLE FOR THE INTENDED USE. THE AWL IS NOT DESIGNED TO BE SUBJECTED TO NON-AXIAL OR LATERAL FORCES, OR BE IMPACTED WITH A HAMMER OTHER THAN THE PROVIDED INSTRUMENT. THE CONDITION OF THE AWL SUGGESTS THAT A LATERAL LOAD WAS APPLIED TO THE TIP OF THE INSTRUMENT AND/OR ANOTHER HAMMER (POSSIBLY METAL) WAS USED REPEATEDLY. EITHER SCENARIO COULD HAVE CAUSED THE TIP TO BREAK OFF. THE BREAK PLANE APPEARED TO BE THE RESULT OF A SHEAR BREAKAGE. HOWEVER, WITHOUT ADDITIONAL INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT IS INDETERMINATE FROM A DESIGN 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) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE LAST HOLE, 2ND LEVEL OF A ZERO-P PROCEDURE, THE SURGEON INSERTED THE ANGLED AWL AND THE TIP BROKE OFF. THE FRAGMENT WAS RETRIEVED IMMEDIATELY, AND THE SURGEON INSERTED THE SCREW AND WAS ABLE TO FINISH THE CASE WITH NO FURTHER PROBLEM. ALL FRAGMENTS WERE RETRIEVED. THIS REPORT IS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171963 2.0MM ANGLED AWL OVE SYNTHES GMBH 1837473

    Patients

    Seq Age Sex Outcome Treatment
    1