BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE

    MDR report key: 8745328 · Received June 28, 2019

    Report

    Report Number
    8030965-2019-65869
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    January 1, 2019
    Report Date
    June 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649491
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. H10 ADDITIONAL NARRATIVE: B6: UPDATED. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD . DEVICE HISTORY LOT MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 10-MAY-2018. EXPIRATION DATE: 01-MAY-2028. PART NUMBER: 04.037.015S, 10MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE. LOT NUMBER: H630642 (STERILE). LOT QUANTITY: 5. ONE PIECE WAS SCRAPPED IN CELL AT OP #60, BEND, FOR A SET-UP RELATED FAILURE. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL, MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AC WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 15012 SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: PART NUMBER: 04.037.912.2, LOCK PRONG 125 DEGREE, TFNA, BP55, LOT NUMBER: L835762, LOT QUANTITY: 93. NOTE: PARTS ORIGINALLY RECEIVED AS P/N 04.037.942.2 WHICH WAS INCORRECT. NR-0080196 WAS INITIATED. THE PARTS RECEIVED WERE ACTUALLY 04.037.912.2, 125 DEGREE LOCK PRONGS. LABELS WERE REWORKED TO REFLECT THE CORRECT P/N 04.037.912.2. PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. WORK ORDER TRAVELERS MET ALL INSPECTION ACCEPTANCE CRITERIA AFTER THE REWORK OF THE LABELS. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55. LOT NUMBER: H529608; LOT QUANTITY: 1,000. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED 06-APR-2018 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58. LOT NUMBER: H580706; LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMO AGRI 16.00, BP80. LOT NUMBER: H457679; LOT QUANTITY: 1,046 LBS. CERTIFIED TEST REPORT RECEIVED FROM PERRYMAN COMPANY DATED 17-AUG-2017 AND CERTIFICATE OF ANALYSIS SUPPLIED TO PERRYMAN BY METALWERKS PMD, INC. DATED 12-MAY-2016 WERE REVIEWED. IT WAS IDENTIFIED DURING THIS REVIEW THAT THE CERTIFICATE OF ANALYSIS SUPPLIED BY METALWERKS TO PERRYMAN HAS A DIFFERENT HEAT NUMBER DOCUMENTED. THE HEAT NUMBER ON THE PERRYMAN CERTIFIED TEST REPORT AND ON THE REMAINDER OF THE DOCUMENTATION. THE HEAT NUMBER ON THE METALWERKS CERTIFICATE OF ANALYSIS IS DOCUMENTED. THIS DISCREPANCY IS BEING INVESTIGATED. LOT SUMMARY REPORT DATED 15-SEP-2017 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 20-JUN-2019: 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. H3, H6: INVESTIGATION SUMMARY UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL. INITIALLY, THE REPORTED DEVICE WAS IMPLANTED LAST JANUARY 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. FLOW: DAMAGE. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) IDENTIFIED THE NAIL BROKE AT THE PROXIMAL HOLE. THE BREAK IS JAGGED AND OBLIQUE. BOTH NAIL PORTIONS WERE RETURNED. NO NEW ISSUES WERE IDENTIFIED. A DEVICE FAILURE WAS IDENTIFIED. BASED ON THE REVIEW OF THE ABOVE DRAWINGS, NO DESIGN ISSUES CONTRIBUTING TO RELEVANT COMPLAINT CONDITION WERE IDENTIFIED. REVIEW OF THE MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    EVENT YEAR REPORTED AS 2019; EXACT DATE OF POSTOPERATIVE NAIL BREAKAGE IS UNKNOWN. IMPLANTED IN (B)(6) 2019; EXACT DATE IS UNKNOWN. THE DEVICE HAS BEEN 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT HAD TO UNDERGO A REVISION PROCEDURE DUE TO A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL. INITIALLY, THE REPORTED DEVICE WAS IMPLANTED IN (B)(6) 2019 TO TREAT THE REVERSED OBLIQUE FRACTURE OF THE PROXIMAL FEMUR. CALLUS STARTED TO FORM, THIS WAS VISIBLE ON THE RX. A WEEK LATER, THE PATIENT SUFFERED FROM PAIN AND DURING THE RX CONTROL IT TURNED OUT THAT THE NAIL WAS BROKEN. ALL THE IMPLANTS WERE SUCCESSFULLY EXPLANTED DURING REVISION PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: TFNA SCREW (PART # 04.038.190S, LOT # H634320, QUANTITY 1); LOCKING SCREW (PART # 04.005.526, LOT # 1L54327, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540212 10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H630642 07611819649491

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN.| TFNA SCR PERF L90 TAN.| LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN| TFNA SCR PERF L90 TAN