BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FEM NAIL Ø11 R 125° L360 TIMO15

    MDR report key: 9565913 · Received January 8, 2020

    Report

    Report Number
    8030965-2020-00173
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    January 1, 2019
    Report Date
    December 12, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: JUL 29, 2016, EXPIRATION DATE: JUL 01, 2026, PART NUMBER: 04.037.126S, 11MM/125 DEG TI CANN TFNA 360MM/RIGHT- STERILE, LOT NUMBER: H140964 (STERILE), LOT QUANTITY: 6 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS/INSPECT DIMENSIONAL/FINAL NS063040 REV C MET ALL INSPECTION ACCEPTANCE CRITERIA INSPECTION SHEET, TFNA ASSEMBLY INSPECTION NS067861 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF REV AB WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 12713 SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.037.912.2, LOCK PRONG, 125 DEGREE TFNA, BP55, LOT NUMBER: 9897557, LOT QUANTITY: 94. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. LOT WAS REWORKED DUE TO THE LICENSE PLATE LABEL BEING PLACED ON THE SURFACE OF THE OUTER BAG INSTEAD OF INSIDE THE BAG TO BE PLACED AFTER THERMAL RINSE. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55, LOT NUMBER: 9850951, LOT QUANTITY: 1,002. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS062851 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATE AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED NOV 13, 2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58, LOT NUMBER: H107444, LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, NS062925 REV D MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80, LOT NUMBER: H055635, LOT QUANTITY: 972 LBS. CERTIFIED TEST REPORT SUPPLIED BY PERRYMAN COMPANY DATED 01-FEB-2016 AND CERTIFICATE OF TEST SUPPLIED TO PERRYMAN BY HOWMET CASTINGS DATED 31-JUL-2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 04-MAR-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY REVIEW JAN 16, 2020: DHR REVIEWED THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. B3: DATE OF EVENT IS AN UNKNOWN DATE IN 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 · 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. 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

    THE PATIENT WAS ORIGINALLY OPERATED ON DUE TO A BISPHOSPHONATE-TYPE FRACTURE. THE PATIENT HAD INCREASING PAIN NOTED ON (B)(6) 2019 WHICH LED TO THE X-RAY BEING TAKEN AND CONFIRMING THAT THE NAIL WAS FOUND TO HAVE BROKEN. THE PATIENT WAS REVISED WITH A LATERAL FEMORAL NAIL (LFN).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TFNA NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. (B)(4). 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 THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANT REVISION SURGERY ON (B)(6) 2019. THE NAIL HAD BROKEN AT THE LAG SCREW JUNCTION. PATIENT WAS REVISED TO A NEW TFNA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE. CONCOMITANT DEVICES: LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN UNKNOWN TFNA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28585 TFNA FEM NAIL Ø11 R 125° L360 TIMO15 ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H140964

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE| UNK - SCREWS: LOCKING