BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/420MM/RT-STERILE

    MDR report key: 16477925 · Received March 3, 2023

    Report

    Report Number
    8030965-2023-02600
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    February 9, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819779624
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE EXPERT LFN Ø12 R CANN L420 TAN. AS THE EVENT DESCRIPTION UPDATE MENTIONS, THIS ADVERSE EVENT IS DUE TO A CHANGE FROM LFN TO TFNA, HENCE THERE IS NO ALLEGATION OR REPORTED DEFECT AGAINST THE DEVICE. THE NAIL ONLY PRESENTS SIGNS OF HEAVY DRILLING MARKS AT THE OUTER SURFACE OF THE PROXIMAL RECON LOCKING SCREWS, IT IS PROBABLE THAT EITHER A FREEHAND DRILLING TECHNIQUE WAS USED OR THE DRILL SLEEVES WERE NOT FULLY ENGAGED TO THE SURFACE OF THE NAIL, AIMING THE DRILL BIT OFF-DIRECTION. THE EXPERT LFN LATERAL FEMORAL NAIL SURGICAL TECHNIQUE GUIDE WAS REVIEWED, FOLLOWING STATEMENT WAS FOUND: PRECAUTION: DO NOT EXERT FORCE ON THE AIMING ARM, PROTECTION SLEEVE, DRILL SLEEVES OR DRILL BITS. SUCH FORCE MAY PREVENT ACCURATE TARGETING THROUGH THE PROXIMAL LOCKING HOLES AND DAMAGE THE DRILL BITS. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE EXPERT LFN Ø12 R CANN L420 TAN AND MET SPECIFICATIONS. A FUNCTIONAL TEST WAS PERFORMED, THE NAIL, AIMING ARM, INSERTION HANDLE, BOTH PROTECTION SLEEVES AND DRILL BITS WERE ASSEMBLED AND A SIMULATION OF THE DRILL BIT MOVEMENT WAS PERFORMED, ALL OF THE DEVICES LINE UP IN ACCORDANCE TO THE PROXIMAL RECON SCREW HOLES, THERE ARE NO SIGNS OF MISALIGNMENT THAT COULD CONTRIBUTE TO THE VISIBLE DAMAGE. THE DRILL MARKS ON THE NAIL COULD BE ATTRIBUTED TO THE USER NOT FOLLOWING THE SURGICAL TECHNIQUE GUIDE AS THE DRILL SLEEVES OR ANY OTHER DEVICES DO NOT PRESENT ANY SIGNS OF SIMILAR DRILL MARKS OR IMPACTION DAMAGE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE EXPERT LFN Ø12 R CANN L420 TAN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: LATERAL ENTRY FEMORAL NAIL, 12MM RIGHT. DIMENSIONAL INSPECTION: MEASURED DIMENSIONS: OUTER DIAMETER AT THE PROXIMAL SECTION OF THE SHAFT = CONFORMING. DIAMETER OF THE 2ND AND 3RD MOST PROXIMAL LOCKING SCREWS = CONFORMING. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER NAME & ADDRESS: (B)(6) HOSPITAL. (B)(6), GERMANY. 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.

    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. D10: DATE OF CONCOMITANT THERAPY IS (B)(6) 2023. H3, H4, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DUE TO A SIGNIFICANT INTRAOPERATIVE INCIDENT WITH THE TFNA. THE HOSPITAL WILL NO LONGER USE THE TFNA. SO NO SUTURING ETC. HAS BEEN DONE YET. THIS REPORT IS FOR ONE (1) EXPERT LFN Ø12 R CANN L420 TAN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THERE WAS AN ISSUE WITH A LATERAL FEMORAL NAIL (LFN). AS A RESULT, THE SURGEON OPTED TO INSTEAD USE A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). THIS REPORT IS FOR A 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/420MM/RT-STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947744 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/420MM/RT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 8979372 07611819779624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention AIM-ARM F/LFN| CONNECSCR CANN F/EXPERT TN+FN F/03.010.0| CONNECSCR CANN F/EXPERT TN+FN F/03.010.0| DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC| DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC| HIP SCR Ø6.5 SELF-TAP L85 F/EXPERT LFN T| HIP SCR Ø6.5 SELF-TAP L90 F/EXPERT LFN T| INSERT-HANDLE F/EXPERT TN+FN| LOCKSCR Ø5 L46 F/NAILS TAN LIGHT GREEN| PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK| PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK| PROTECT SLEEVE 12/8 L188| TROCAR Ø3.2 F/03.010.076| TROCAR Ø3.2 F/03.010.076| TROCAR Ø3.2 F/03.010.076| TROCAR Ø3.2 F/03.010.076| TROCAR Ø4.2 F/03.010.065| TROCAR Ø4.2 F/03.010.065