BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 4449817 · Received January 26, 2015

    Report

    Report Number
    3003875359-2015-10059
    Event Type
    Malfunction
    Date Received
    January 26, 2015
    Report Date
    January 12, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    (B)(6). PRODUCT INVESTIGATION EVALUATION: ONE 2.0MM ANGLED AWL (PART 03.617.993, LOT 3067631, MFG FEB 2009) WAS RETURNED WITH THE COMPLAINT THAT ¿THE TIP ON AN ANGLED AWL BROKE DURING IMPACTION BECAUSE IT HIT A DISTRACTOR PIN THAT WAS IN THE SAME VICINITY. THE BROKEN TIP WAS REPORTEDLY EASILY RETRIEVED WITH NO COMPLICATIONS.¿ UPON RECEIPT OF THE DEVICE, IT WAS SEEN THAT THE DISTAL TIP OF THE AWL IS NO LONGER CONNECTED TO THE DEVICE. THE AWL IS USED TO CREATE SCREW HOLES FOR FIXATION OF THE ZERO-P SPACER IN CERVICAL INTERBODY FUSION PROCEDURES. DURING IMPLANTATION, THE AWL IS INSERTED AT THE APPROPRIATE ANGLE INTO THE SCREW HOLE OF THE SPACER PLATE AND THEN TAPPED WITH A SLOTTED MALLET TO CREATE THE SCREW HOLES PER THE TECHNIQUE GUIDE. THE DRAWINGS FOR THIS DEVICE WERE REVIEWED. THIS DEVICE WAS MANUFACTURED AT A TIME WHEN THE DRAWING SPECIFIED THE RADIUS AT THE AWL POINT TRANSITION BE 0.5 (MAX). WHEN THIS LOT WAS MANUFACTURED, THE RADIUS DIMENSION COULD BE AS SMALL AS 0.1MM (PER THE INTERNAL RADIUS CALLOUT), WHICH SIGNIFICANTLY WEAKENS THE STRENGTH OF AWL. DIMENSIONAL CHANGES IMPLEMENTED IN THE RECENT VERSIONS OF THE DESIGN MAY REDUCE THE RISK OF THE AWL TIP BREAKING. THE AWL IS INTENDED TO CONTACT BONE, NOT HARDWARE, AND AS THIS COMPLAINT STATES THAT A DISTRACTOR PIN WAS HIT DURING IMPACTION. THUS, THE ROOT CAUSE OF THIS COMPLAINT IS THE AWL HITTING THE DISTRACTOR PIN. DEVICE 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 THE TIP ON AN ANGLED AWL BROKE DURING IMPACTION BECAUSE IT HIT A DISTRACTOR PIN THAT WAS IN THE SAME VICINITY. THE BROKEN TIP WAS REPORTEDLY EASILY RETRIEVED WITH NO COMPLICATIONS. THE ANGLED AWL WAS BEING USED TO PLACE A STARTER HOLE. ON IMPACTION THE TIP BROKE OFF THE AWL; THE INSTRUMENT WAS REMOVED AND A NEEDLE DRIVER WAS USED TO REMOVE THE BROKEN TIP WITHOUT DELAY. IT WAS NOTED THAT THE AWL TIP PROBABLY CONTACTED THE DISTRACTOR PIN IN THE SAME VERTEBRAL BODY AT THE SAME ANGLE, CAUSING IT TO BREAK OFF. THE DISTRACTOR PIN WAS REMOVED AND THE SCREWS WERE PLACED IN THE USUAL FASHION. THE PATIENT STATUS FOLLOWING THE SURGERY WAS STABLE, WITH NO KNOWN INTRA-OPERATIVE COMPLICATIONS FROM THIS INCIDENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60492 2.0MM ANGLED AWL INTERVERTEBRAL FUSION DEVICEW/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 3067631

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR