BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 75MM STERILE.

    MDR report key: 9856749 · Received March 19, 2020

    Report

    Report Number
    8030965-2020-02121
    Event Type
    Injury
    Date Received
    March 19, 2020
    Report Date
    February 21, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819652415
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H6: MANUFACTURING LOCATION: ELMIRA / MONUMENT MANUFACTURING DATE: JANUARY 16, 2019, EXPIRATION DATE: JANUARY 01, 2029, PART: 04.038.275S, TFNA HELICAL BLADE 75MM -STERILE, LOT: H798074 (STERILE). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS MET ALL INSPECTION ACCEPTANCE CRITERIA. LOT WAS REWORKED (VIBRATORY TUB) FOR AN UNEVEN SURFACE FINISH. ALL PARTS WERE DETERMINED TO BE ACCEPTABLE AFTER REWORK. INSPECTION SHEET, FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. STERILIZATION CONTROL NUMBER (SCN) SUPPLIED BY STERIGENICS 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. 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 · 0

    REOPERATION WAS COMPLETED SUCCESSFULLY ON (B)(6) 2020, BY REMOVING ALL IMPLANTS AND REPLACING WITH ARTIFICIAL BONE HEAD.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A SURGERY FOR A FEMORAL INSTABILITY FRACTURE. AFTER THE SURGERY THE BLADE PENETRATED THE BONE HEAD. THE SURGEON COMMENTED THAT THE CALLUS INTERFERED WITH THE SLIDING BECAUSE THE FRACTURE SITE WAS NEAR THE INSERTION POINT OF THE BLADE. THE SURGEON IS CONSIDERING A REVISION TO REMOVE THE DEVICES. CONCOMITANT DEVICES: TROCHANTERIC FIXATION NAIL (TFNA) (PART# :04.037.918S; LOT# 9873662; QUANTITY: 1) T25 STARDRIVE LOCKING SCREW32MM (PART#:04.005.522S; LOT#:6L01520; QUANTITY: 1) END CAPS (PART# 04.038.000S; LOT#:5L44854; QUANTITY: 1). THIS REPORT IS FOR ONE TFNA HELICAL BLADE 75MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320527 TFNA HELICAL BLADE 75MM STERILE. ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H798074 07611819652415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5.0MM TILOCKSCREW WT25 STARDRIVE 32MM FIM NAILSTER| LOCKSCR Ø5 L32 F/NAILS TAN LIGHT GREEN| TFNA END CAP EXTENS. 0 TAN| TFNA FEM NAIL Ø9 R 125° L280 TIMO15