BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 200MM - STERILE

    MDR report key: 8573430 · Received May 2, 2019

    Report

    Report Number
    8030965-2019-63385
    Event Type
    Injury
    Date Received
    May 2, 2019
    Report Date
    April 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649958
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE HISTORY, PART NUMBER: 04.037.043S, 10MM/130 DEG TI CANN TFNA 200MM ¿ STERILE, LOT NUMBER: H051641 (STERILE) , MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 10-MAR-2016, EXPIRATION DATE: 31-MAR-2026, LOT QUANTITY: (B)(4). ONE PIECE WAS SCRAPPED IN CELL AT OP #160, QA FINAL INSPECT, FOR AN INSIDE DIAMETER FAILURE DUE TO BURRS. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL, NS063029 REV E MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. 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 12300 SUPPLIED BY EES (ALBUQUERQUE) 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 PARTS REVIEWED: PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA BP55, LOT NUMBER: 9804358, LOT QUANTITY: (B)(4). PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED BP55, LOT NUMBER: 9850948, LOT QUANTITY: (B)(4). 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 SUPPLIED BY SMALLEY DATED 16-OCT-2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE BP58, LOT NUMBER: H043205, LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00 BP80, LOT NUMBER: 7855489, LOT QUANTITY: (B)(4). CERTIFICATE OF ANALYSIS SUPPLIED BY METALWERKS PMD, INC. DATED 20-OCT-2014 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 14-NOV-2014 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 05-APR-2019: DHR REVIEWED BY: (B)(4). 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. 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

    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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH THE TROCHANTERIC FEMORAL NAILING ADVANCED SYSTEM (TFNA) FOR A FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2018. THE CONDITION OF THE CRUSHED BONE WAS BAD. AN OBLIQUE FRACTURE WAS ALSO OBSERVED AROUND THE SUBTROCHANTERIC AREA. HOWEVER, ON (B)(6) 2019, X-RAYS WERE TAKEN WHEN THE PATIENT VISITED THE HOSPITAL AND SHOWED A SLIGHT VARUS OF THE FEMORAL HEAD, BROKEN TFNA NAIL AT THE HOLE OF THE BLADE, AND TELESCOPING OF THE TFNA BLADE AT 10MM. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) . THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 200MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366060 10MM/130 DEG TI CANN TFNA 200MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H051641 07611819649958

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN SCREWS| UNKNOWN SCREWS