BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE

    MDR report key: 9576275 · Received January 10, 2020

    Report

    Report Number
    8030965-2020-00238
    Event Type
    Injury
    Date Received
    January 10, 2020
    Report Date
    December 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819650114
    PMA / PMN Number
    K160167
    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. 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

    NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. DAMAGED DEVICE WAS EASILY WITH A MINIMAL STRUGGLE FOR THE SURGEON FOLLOWED BY FURTHER SURGERY TO STABILIZE THE PROXIMAL FEMUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: SEPTEMBER 29, 2016. EXPIRATION DATE: SEPTEMBER 01, 2026. PART: 04.037.059S, 10MM/130 DEG TI CANN TFNA 380MM/LEFT ¿ STERILE. LOT: H052636 (STERILE). ONE PIECE WAS SCRAPPED DUE TO A FUNCTIONAL GAGE FAILURE. THE REMAINDER OF THE LOT WAS 100% INSPECTED FOR THIS FEATURE AND DETERMINED TO BE ACCEPTABLE. 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 LPPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. STERILIZATION CONTROL NUMBER (SCN) 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 PART(S) REVIEWED: PART: 04.037.942.2, LOCK PRONG 130 DEGREE, TFNA, BP55. LOT: 9904507. PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55. LOT: H089450. 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 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART: 04.037.912.3, TFNA LOCK DRIVE, BP58. LOT: H171723. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART:21127, TIMOAGRI16.00, BP80. LOT: 7882184. CERTIFICATE OF ANALYSIS SUPPLIED BY METALWERKS PMD WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 REVISION SURGERY ON (B)(6) 2019, DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. PATIENT WAS REVISED TO A PROXIMAL FEMORAL PLATE. THE TFNA NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON PUT THE BREAKAGE DOWN TO THE NON-UNION OF THE FEMUR AND DUE TO THE LACK OF BONE AROUND THE NAIL AND THE PATIENT WALKING ON IT FOR A YEAR. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: 04.038.385S, LOT: H667651, QUANTITY# 1), TFNA END CAP (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 10MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39495 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H052636 07611819650114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TFNA HELICAL BLADE PERF L85 TAN| UNK - END CAPS: TFNA| UNK - SCREWS: LOCKING