BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 11124499 · Received January 6, 2021

    Report

    Report Number
    8030965-2021-00091
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    December 8, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    UDI-DI
    07611819933330
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4, D9, H3, H4, H6: PART: 03.617.993. LOT: 7713121. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 09.JAN 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE VISUAL INSPECTION CONFIRMED THAT THE TIP OF AWL Ø2 ANGL IS BROKEN OFF. THE BROKEN TIP IS NOT RETURNED FOR FURTHER EVALUATION AND IS MISSING. AT THE HANDLE SIDE THERE ARE DENTS FROM HAMMER-BLOWS VISIBLE. ACCORDING OF THE RECEIVED PICTURE, SHOWN THAT THE BROKEN TIP IS WORN AND HAS WEAR MARKS VISIBLE. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 1.4028 STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL. SUMMARY: THE RETURNED AWL WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. THE TIP OF AWL Ø2 ANGL IS BROKEN OFF AND IS NOT RETURNED FOR FURTHER EVALUATION. ACCORDING OF THE RECEIVED PICTURE, SHOWN THAT THE BROKEN TIP IS WORN AND HAS WEAR MARKS VISIBLE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE VISIBLE SIGNS, LIKE WORN MARKS ON THE TIP, INDICATE STRONG APPLIED MECHANICAL FORCE DURING USE OF THE AWL. THEREFORE WE HAVE TO ASSUME THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE, WELL BEYOND ITS CALCULATED DESIGN CAUSED THE BREAKAGE OF THE TIP. THE BREAKAGE COULD BE ALSO AN RESULT OF A MECHANICAL OVERLOAD SITUATION DURING A LONG TIME PERIOD (9 YEAR) IN USE. THIS PRODUCTION LOT WAS MANUFACTURED IN JANUARY 2012 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATIONS. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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.

    Additional Manufacturer Narrative · 1

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL PRODUCT CODE: KWQ. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION, AS IT IS VISIBLE THAT THE TIP SECTION IS BROKEN OFF, BASED ON THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED THEREFORE NO FURTHER INVESTIGATION POSSIBLE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE (INFORMATION OR/AND MATERIAL), THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WHEN THE SURGEON REMOVED THAT AWL, THE AWL BROKE OFF IN THE PATIENT. THE SURGEON USED FORCEPS TO REMOVE THE FRAGMENTS FROM THE PATIENT. THE FRAGMENTS WERE EASILY REMOVED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE STRAIGHT AWL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT INVOLVES ONE (1) 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19692 2.0MM ANGLED AWL INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE SYNTHES GMBH 7713121 07611819933330

    Patients

    Seq Age Sex Outcome Treatment
    1