BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    MDR report key: 8709507 · Received June 18, 2019

    Report

    Report Number
    8030965-2019-65442
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    March 30, 2019
    Report Date
    March 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819004665
    PMA / PMN Number
    K161616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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. THIS REPORT WAS ORIGINALLY REPORTED UNDER DEPUY MEDWATCH REPORT 1818910-2019-90171. WHILE INVESTIGATING THIS COMPLAINT IT WAS DETERMINED THE DEVICE WAS A SYNTHES DEVICE AND A NEW INITIAL REPORT WAS SUBMITTED. PMA/510K: AWARENESS DATE SHOULD HAVE BEEN JUNE 18, 2019. 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

    ADDITIONAL DEVICE PRODUCT CODE: KTT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 214.840, LOT: 2L75212. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 17. DEC. 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: RELEASED TO BLANK STORAGE ON 03-APR-2017. PART NUMBER: 214.040.999, 4.6 MM SCREW BLANK 40 MM 04.5 CORTEX SCREW W/3.5 HEX. LOT NUMBER: H332668 (NON-STERILE). LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. COMPONENT PART(S) REVIEWED: PART NUMBER: 13008, 316LC*RI4.58. LOT NUMBER: H130052. LOT QUANTITY: (B)(4). THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE THREADED PART OF THE SCREW IS BROKEN AT THE RUN OUT OF THE THREAD, ONLY THE SCREW HEAD OF THE CORTEX SCREW WAS RETURNED. THERE IS A CLEARLY VISIBLE STRESS MARK AT THE BOTTOM OF THE SCREW HEAD AND IN THE HEXAGON RECESS ARE IMPRESSIONS OF THE SCREWDRIVER VISIBLE. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE AS THE BREAKAGE OCCURRED AT THE RUN OUT OF THE THREAD. DRAWING/SPECIFICATION REVIEW: THE REVIEW OF THE MANUFACTURING DOCUMENTS DID SHOW NO DEVIATION FROM THE SPECIFICATION. (B)(4). SUMMARY: THE COMPLAINT IS CONFIRMED AS THE RECEIVED CORTCEX SCREW IS BROKEN AS COMPLAINED. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN DECEMBER 2018 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION. BASED ON THAT, THE REVIEW OF THE MANUFACTURING DOCUMENTS AND THE VISIBLE DAMAGES AT THE HEAD SCREW LET US EXCLUDE A MANUFACTURING RELATED ISSUE. THE FRACTURE FACE IS HOMOGENOUS AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THIS, THE STRESS MARK AT THE BOTTOM OF THE SCREW HEAD AND THE IMPRESSION MARKS IN THE HEXAGON INDICATE THAT A MECHANICAL OVERLOAD DURING INSERTION CAUSED THE BREAKAGE OF THE CORTEX SCREW. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 (B)(6) 2019, DURING INSERTION OF DYNAMIC HIP SCREW SYSTEM FOR TROCHANTERIC FRACTURE, A CORTEX SCREW HEAD HAD SNAPPED OFF IN DHS PLATE. THE SURGEON SAID THAT THERE WAS NO EXCESSIVE FORCE WAS APPLIED VISIBLY. THE SCREW CORE AND THREAD WERE REMAINED IN THE PATIENT'S BODY. THERE WAS NO SURGICAL DELAY. SURGICAL PROCEDURE WAS COMPLETED BY INSERTING SCREWS IN THE REMAINING HOLES OF PLATE. THERE WAS NO PATIENT HARM REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DHS PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 4.5 MM CORTEX SCREW SELF-TAPPING 40 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500478 4.5MM CORTEX SCREW SELF-TAPPING 40MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 2L75212 07611819004665

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES: DHS/DCS