BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø10 LONG LE 130° L320 SST

    MDR report key: 8244113 · Received January 14, 2019

    Report

    Report Number
    8030965-2019-59829
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    December 17, 2018
    Report Date
    December 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819997028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ADDITIONAL NARRATIVE: DATE OF EVENT. 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. DEVICE HISTORY LOT, PART: 02.027.223S, LOT: 9543121, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 01. JULY 2015, EXPIRY DATE: 01. JUNE 2025. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 12 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. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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. THE RAW MATERIAL CERTIFICATE 18387 WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO ISO-5832-1 SPECIFICATION FOR IMPLANTS FOR SURGERY. 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

    PART OF DEVICE REMAINED IN PATIENT, SO DEVICE NOT CONSIDERED EXPLANTED DURING PROCEDURE ON (B)(6) 2018. IT IS UNKNOWN IF THE COMPLAINANT PART IS AVAILABLE TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT IT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL OF PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA). ORIGINALLY, THE DEVICE WAS IMPLANTED THROUGH CLOSED REDUCTION INTERNAL FIXATION ON (B)(6) 2016 DUE TO SUBTROCHANTERIC FEMORAL FRACTURE (LEFT). AFTER REMOVAL OF AN UNKNOWN LOCKING BOLT, THE UNKNOWN BLADE COULD NOT BE RELEASED BUT THE REMOVAL WAS SUCCESSFUL. WHILE HITTING OUT OF THE NAIL UNDER CONTROL WITH AN IMAGER THE DISTAL PART OF THE NAIL FROM THE LOCKING HOLE ON BROKE OFF AND REMAINED INSIDE THE MARK. ON THE IMAGES PREOPERATIVELY, THERE WAS NO EVIDENCE FOR ANY MATERIAL FRACTURE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY AND ADVERSE EVENT TO THE PATIENT REPORTED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BLADE (PART/LOT UNKNOWN, QUANTITY 1). LOCKING BOLT (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A PFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36440 PFNA Ø10 LONG LE 130° L320 SST ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9543121 07611819997028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention