BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    MDR report key: 7742254 · Received August 2, 2018

    Report

    Report Number
    8030965-2018-55437
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    July 12, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE 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. 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 · 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. DHR REVIEW WAS COMPLETED. PART: 214.840 . LOT: L440180 . MANUFACTURING SITE: MEZZOVICCO . RELEASE TO WAREHOUSE DATE: 31 MAY 2017 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 240 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. LOT L440180 WAS MANUFACTURED FROM BLANK 214.040.999 LOT H332660. MANUFACTURED IN THE US, MONUMENT . MANUFACTURING LOCATION: MONUMENT . MANUFACTURING DATE: RELEASED TO BLANK STORAGE ON 03-APR-2017 . PART NUMBER: 214.040.999 4.6MM SCREW BLANK 40MM 04.5 CORTEX SCREW W/3.5 HEX. LOT NUMBER: H332660 (NON-STERILE) . LOT QUANTITY: 911 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. COMPONENT PART(S) REVIEWED: PART NUMBER: 13008 316LC*RI4.58 LOT NUMBER: H130052. LOT QUANTITY: 4,221 LBS. CERTIFICATE OF TESTS RECEIVED FROM CARPENTER TECHNOLOGY DATED 25-MAY-2016 WAS REVIEWED AND FOUND TO BE CONFORMING. LOT SUMMARY REPORT DATED 21-JUN-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 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. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. A POST-OPERATIVELY BROKEN CORTSCR Ø4.5 SELF-TAP L40 SST WAS RETURNED FOR INVESTIGATION. THE IMPLANT WAS FORWARDED TO THE MANUFACTURING SITE (SYNTHES MEZZOVICO) AND WAS CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS CORTSCR Ø4.5 SELF-TAP L40 SST WAS MANUFACTURED IN MAY 2017 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. A VISUAL INSPECTION HAS BEEN PERFORMED AND IT CONFIRMED THAT THE RECEIVED CONDITION AGREES WITH THE COMPLAINT CONDITION BUT NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEM. THE DIMENSIONAL RE-INSPECTION, THE RAW MATERIAL CERTIFICATE REVIEW AND THE DOCUMENT/SPECIFICATION REVIEW DIDN¿T IDENTIFY ANY MANUFACTURING DEFECT OR DEFICIENCY, THUS THE COMPLAINT INVESTIGATION IS CONSIDERED AS NOT MANUFACTURING RELATED. THE CERTIFICATE OF RAW MATERIAL LOT H130052 HAS BEEN REVIEWED: IN THE CERTIFICATE IT IS REPORTED THAT THE MATERIAL IS CONFORMING TO THE SPECIFICATION THE APPLICABLE RISK MANAGEMENT DOCUMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THIS COMPLAINT CONDITION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT 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.

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE IS NOT KNOWN. ADDITIONAL PRODUCT CODE: KTT. INITIAL REPORTER TELEPHONE NOT AVAILABLE. INITIAL REPORTER IS SYNTHES AFFILIATE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE AND SCREW ON (B)(6) 2018. X-RAY TAKEN ON (B)(6) 2018 REVEALED THE PLATE WAS BROKEN. PATIENT WAS RETURNED TO SURGERY ON THE SAME DATE FOR REVISION SURGERY. PATIENT STATUS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 5.0MM LOCKING SCREW SELF-TAPPING 34MM (213.334, LOT L625766, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 36MM (213.336, LOT 9763925, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 36MM (213.336, LOT L277973, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 38MM (213.338, LOT L241635, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 46MM (213.346, LOT 8593682, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 46MM (213.346, LOT 9754055, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 55MM (213.355, LOT L570704, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 65MM (213.365, LOT L631292, QUANTITY 2), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (213.375, LOT L471084, QUANTITY 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (213.375, LOT L487983, QUANTITY 1), CABLE/WIRE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586216 4.5MM CORTEX SCREW SELF-TAPPING 40MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L440180 07611819004665

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention