BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 3506544 · Received December 9, 2013

    Report

    Report Number
    8030965-2013-05464
    Event Type
    Injury
    Date Received
    December 9, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND IT STATES THAT THE 2MM DISTAL TIP SHEARED OFF AND MISSING PORTION WAS NOT RETURNED. ADDITIONALLY, THE MATERIAL SURFACE OF THE AWL SHAFT EXHIBITS SEVERAL SCRATCHES AND SLIGHTLY DISCOLORATION. THE INSTRUMENT (PART NUMBER 03.617.993) IS AN ANGLED AWL USED AS PART OF THE ZERO-PROFILE ANTERIOR CERVICAL FUSION SYSTEM. THE ZERO-P STAND-ALONE IMPLANTS COMBINES A PREASSEMBLED CERVICAL INTERBODY SPACER WITH AN ANTERIOR CERVICAL PLATE AND ARE DESIGNED TO MINIMIZE CONTACT WITH LOCAL ANATOMICAL STRUCTURES AND PREVENT CONTACT WITH ADJACENT LEVELS. THE APPLICABLE TECHNIQUE GUIDE FOR ZERO-P SYSTEM WAS REVIEWED. ONCE THE IMPLANT IS INSERTED THEN THE ZERO-P SCREWS ARE INSERTED AND TIGHTENED. THE SURGEON CAN CHOOSES TO USE A DRILL OR USE AN AWL TO ESTABLISH THE SCREW POSITION; THE ANGLED AWL (PART NUMBER 03.617.993) IS AN OPTION IF THE PATIENT ANATOMY DOES NOT ALLOW THE USE OF STRAIGHT AWL INSTRUMENT (PART NUMBER 03.617.990). THE ZERO-P SCREW IMPLANTS DICTATE THE USE OF THE AWL INSTRUMENT. BASED ON THE EVALUATION RESULTS, IT IS NOT CLEAR HOW THE CONFIRMED CONDITION WAS CAUSED HOWEVER THE DESIGN OF THE AWL INSTRUMENT WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE, NO DESIGN ISSUES WERE IDENTIFIED THAT COULD CONTRIBUTE TO CAUSE THIS COMPLAINT. THE DISPOSITION FOR THIS COMPLAINT FROM A DESIGN PERSPECTIVE IS INDETERMINATE. AN ADDITIONAL EVALUATION WAS CONDUCTED AND IT STATES THAT ONLY THE BROKEN TIP OF THE AWL WAS SENT BACK. TIP IS BENT AND THE CUTTING EDGES ARE BLUNT. THE RELEVANT DIMENSION OF THE TIP WAS CHECKED AND WAS WITHIN THE SPECIFICATION. THE HARDNESS WAS ALREADY CHECKED BEFORE DURING THE MANUFACTURING EVALUATION OF THE REST OF THE AWL. THE FOREFRONT OF THE TIP IS BENT AND THE CUTTING EDGES ARE BLUNT, ALSO IT IS CLEARLY VISIBLE THAT THE SHAFT WAS BENT BEFORE IT BROKE. THIS INDICATES A MECHANICAL OVERLOAD, POSSIBLY BE THE USE OF A BLUNT INSTRUMENT OR AN UNDUE METALLIC CONTACT. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURER EVALUATION WAS CONDUCTED. THE HARDNESS OF THE TIP AND THE RADIUS AT THE FRACTURE FACE WERE CHECKED AND NO DEVIATION WAS FOUND. THE TIP OF THE AWL WAS NOT SENT BACK FOR EVALUATION. HOWEVER, A PICTURE OF THE DEVICE SHOWS THAT THE TIP HAS STRONG STRESS MARKS AND A DEFORMED FOREFRONT. THIS INDICATES THAT THE DEVICE WAS EITHER OVERUSED OR USED IN A BLUNT CONDITION, WHICH CAN LEAD TO A MECHANICAL OVERLOAD.

    Additional Manufacturer Narrative · 1

    DATE OF AWARENESS (B)(6) 2013. ORIGINAL DATE OF AWARENESS IS (B)(6) 2013.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL PROCEDURE ON (B)(6) 2013, THE TIP OF THE ANGLED AWL BROKE OFF AND WAS LEFT IN THE VERTEBRA OF THE PATIENT. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF THE BROKEN TIP BECAUSE IT WAS MIGRATING ANTERIORLY. THE BROKEN TIP WAS REMOVED AND A 12MM SCREW WAS IMPLANTED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637485 2.0MM ANGLED AWL OVE SYNTHES GMBH 3346803

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention