BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    MDR report key: 7377739 · Received March 28, 2018

    Report

    Report Number
    8030965-2018-52514
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 2, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819004665
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PART 214.840, LOT 3366790: RELEASE TO WAREHOUSE DATE: FEBRUARY 10, 2010. MANUFACTURING SITE: MEZZOVICCO. BLANK PART 214.040.999, LOT 6308381: RELEASE TO WAREHOUSE: FEBRUARY 05, 2010. MANUFACTURED IN THE US, MONUMENT. COMPONENTS PART 13008 LOT 6293916 MET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET SPECIFICATION. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE INVESTIGATION HAS SHOWN THAT ONE CORTEX SCREW IS BROKEN AS WELL. THE BREAKAGE OCCURRED AT THE MIDDLE OF THE SHAFT. THE BROKEN OFF PART WAS NOT RETURNED FOR INVESTIGATION. IT IS UNKNOWN IF THE CORTEX SCREW BROKE PRIOR OR DURING REMOVAL SURGERY. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS SCREW WAS MANUFACTURED IN FEBRUARY 2010 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE RELEVANT DIMENSIONS WERE CHECKED AND FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS REVIEW OF RAW MATERIAL CERTIFICATE INDICATES THAT MATERIAL CONFORMS TO SPECIFICATIONS. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED; A MATERIAL OR MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. 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

    HEIGHT OF THE PATIENT IS REPORTED AS 172 CMS. PATIENT¿S IDENTIFIER IS NOT PROVIDED FOR REPORTING. DATE OF POSTOPERATIVE SCREW BREAKAGE IS UNKNOWN. ADDITIONAL PRODUCT CODE: KTT. (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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

    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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT POST-OPERATIVELY A CONDYLAR PLATE BROKE. THE PLATE WAS IMPLANTED ON (B)(6) 2017 AND PATIENT WAS REVISED ON (B)(6) 2018. CONCOMITANT DEVICES REPORTED: CORTSCR Ø4.5 SELF-TAP L42 SST (PART # 214.842, LOT # 99152688, QUANTITY 1), CORTSCR Ø4.5 SELF-TAP L36 SST (PART # 214.836, LOT # L067948, QUANTITY 1), CORTSCR Ø4.5 SELF-TAP L36 SST (PART # 214.836, LOT # L121493, QUANTITY 1), CORTSCR Ø4.5 SELF-TAP L48 SST (PART # 214.848, LOT # 9886958, QTY 1), 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/75MM (PART # 218.075, LOT # 1077, QUANTITY 1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # 1137, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DURING MANUFACTURER¿S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES, IT WAS IDENTIFIED THAT ONE (1) RETURNED CORTEX SCREW IS ALSO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222572 4.5MM CORTEX SCREW SELF-TAPPING 40MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 3366790 07611819004665

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention