BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 40MM

    MDR report key: 8141651 · Received December 7, 2018

    Report

    Report Number
    8030965-2018-58824
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819043169
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. 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. PART 459.440, LOT 5941049: MANUFACTURING SITE: SALZBURG. RELEASE TO WAREHOUSE DATE: DECEMBER 08, 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES 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. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO SPECIFICATIONS FOR IMPLANTS FOR SURGERY. 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. A PRODUCT INVESTIGATION WAS COMPLETED: REPORTEDLY THE BOLT WAS FOUND BROKEN POSTOPERATIVELY. THE FEATURES WERE RE-INSPECTED ARE ALL THE SPECIFICATION PERTINENT TO THE CLAIMED ISSUE IN ORDER TO VERIFY THE CONFORMITY OF RETURNED PARTS. THE MEASURABLE FEATURES PERTINENT TO THE COMPLAINT DESCRIPTION ARE CONFORMING TO SPECIFICATIONS. THE BOLT IS BROKEN POST PRODUCTION DUE TO USE. NO EVIDENCE OF VISUAL NONCONFORMANCE MANUFACTURING RELATED. THE IDENTIFICATION CONFIRMED THAT THE PART CORRESPONDS TO THE ARTICLE 459.400. NO EVIDENCE OF NON-CONFORMANCES MANUFACTURING RELATED. THE PRODUCT IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. 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.

    Description of Event or Problem · 0

    THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES: PFNA HELICAL BLADE (PART: 04.027.038S, LOT: UNKNOWN, QUANTITY: 1).

    Description of Event or Problem · 0

    REPORTEDLY THE PATIENT WAS IMPLANTED WITH A HIP PROSTHESIS (PROXIMAL FEMUR REPLACEMENT). UPDATED CONCOMITANT DEVICE: PFNA BLADE (PART 04.027.038S, LOT L21XXXX, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT REPORTED AS 2018, EXACT DATE IS NOT KNOWN. ADDITIONAL PRODUCT CODES: HTY, JDW, JDS, JDN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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, 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL AND TWO (2) BOLTS ON (B)(6) 2018. ON UNKNOWN DATE IT WAS REVEALED THAT THE NAIL AND TWO (2) BOLTS WERE BROKEN. THIS REPORT IS FOR ONE (1) LOCKING BOLT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983414 4.9MM TI LOCKING BOLT 40MM ROD, FIXATION, BONE HSB OBERDORF SYNTHES PRODUKTIONS GMBH 5941049 07611819043169

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention