BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 4789482 · Received May 21, 2015

    Report

    Report Number
    3003875359-2015-10230
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: A 2.0MM ANGLED AWL (03.617.993 LOT 3009347 MANUFACTURED DECEMBER 15, 2008) WAS RECEIVED WITH A SHEARED OFF DISTAL TIP, WHICH WAS NOT RETURNED. THE COMPLAINT DESCRIPTION STATES THAT WHILE PREPARING A PATHWAY FOR SCREW INSERTION, THE TIP OF THE ANGLED AWL SNAPPED OFF IN THE CERVICAL VERTEBRAL BODY. THE FRAGMENT WAS LEFT IN THE PATIENT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER THE FAILURE MODE IS CONSISTENT WITH FAILURE DUE TO OFF AXIS LOADING. PER THE TECHNIQUE GUIDE, THE 2.0MM ANGLED AWL (PART 03.617.993 LOT 3732765) IS A COMPONENT OF THE ZERO-PROFILE (ZERO-P) ANTERIOR CERVICAL INTER-BODY FUSION (ACIF) SYSTEM. THE ZERO-P STAND-ALONE IMPLANTS COMBINE A PREASSEMBLED CERVICAL INTER-BODY SPACER WITH AN ANTERIOR CERVICAL PLATE AND ARE DESIGNED TO MINIMIZE CONTACT WITH LOCAL ANATOMICAL STRUCTURE AND PREVENT CONTACT WITH ADJACENT LEVELS. THE ANGLED AWL IS SPECIFICALLY DESIGNED TO BE USED AS AN ALTERNATIVE TO THE DRILL FOR VERTEBRAL BODY PREPARATION. THE ANGLED AWL IS POSITIONED INTO THE APPROPRIATE IMPLANT SCREW HOLE AND TAPPED WITH THE SLOTTED MALLET UNTIL THE AWL IS FULLY SEATED. AT THIS POINT THE AWL CAN BE REMOVED AND THE SCREW INSERTED. THE MATERIAL AT THE FRACTURE SITE APPEARS TO BE HOMOGENEOUS UNDER MAGNIFICATION; THEREFORE IT IS UNLIKELY THAT A MATERIAL IMPERFECTION LED TO THE PART FAILURE. RATHER IT IS LIKELY THAT A MECHANICAL OVERLOAD SITUATION OCCURRED, AS A FORCE GREATER THAN THE ULTIMATE SHEAR STRENGTH OF THE MATERIAL WAS APPLIED. WITHOUT FURTHER DETAILS AS TO HOW THE DEVICE WAS USED DURING THE SURGERY AND WITHOUT THE RETURN OF THE BROKEN OFF COMPONENT, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE ROOT CAUSE FOR THE FAILURE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A SURGEON WAS PREPARING A PATHWAY FOR SCREW INSERTION, THE TIP OF A 2.0 MM ANGLED AWL, PART NUMBER 03.617.993, SNAPPED OFF IN THE CERVICAL VERTEBRAL BODY. THE PIECE REMAINED RETAINED IN PATIENT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS A 15 MINUTE SURGICAL DELAY DUE TO THE COMPLAINED EVENT. PATIENT STATUS AS OF (B)(6) 2015 IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332790 2.0MM ANGLED AWL INTERVERTEBRAL FUSION DEVICEW/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 3009347

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention