BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE

    MDR report key: 7342480 · Received March 15, 2018

    Report

    Report Number
    8030965-2018-52109
    Event Type
    Injury
    Date Received
    March 15, 2018
    Report Date
    February 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819651739
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: MANUFACTURING LOCATION: MONUMENT , MANUFACTURING DATE: 10-MAR-2016 , EXPIRATION DATE: 31-MAR-2026 . PART #: 04.037.915S, LOT#: H050503 (STERILE) - 9MM/125 DEG TI CANN TFNA 235MM/LEFT- STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: 04.037.912.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT ¿ 9641592 , 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 9937529 , 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9929357 , 21127 - RAW MATERIAL LOT BP-80 LOT ¿ 7855489 . RAW MATERIAL RECEIVED FROM METALWERKS PMD INC. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS PMD INC. FOR TITANIUM MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION MEET SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SCN NO: 12293, ETHICON (ABQ), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ A INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: THIS COMPLAINT IS CONFIRMED. THE RETURNED NAIL HAS BROKEN AT THE DISTAL LOCKING HOLE. THE SLIGHTLY OBLIQUE FRACTURE LINE CREATED A JAGGED BREAK PATTERN. ADDITIONALLY, THE PROXIMAL PORTION OF THE RETURNED NAIL IS STUCK TO THE EXTRACTION DEVICE AND WAS UNABLE TO SEPARATED AT CUSTOMER QUALITY. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) VIA FUNCTIONAL TEST IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. THE NAIL WAS MANUFACTURED IN MARCH 2016 AND IS OVER 2 YEARS OLD. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. A DIMENSIONAL INSPECTION OF FEATURES RELEVANT TO THIS COMPLAINT COULD NOT BE OBTAINED AT CQ DUE TO THE POST MANUFACTURING DAMAGE. TABULATED PRODUCT DRAWING 04_037_012 FOR THE FAMILY OF 125 DEGREE TITANIUM CANNULATED TROCHANTERIC FIXATION NAILS-ADVANCE WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION AND THE COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) NAIL FOR FEMORAL TROCHANTERIC FRACTURE (LEFT) ON (B)(6) 2017. THREE (3) MONTHS AFTER THE INITIAL SURGERY, PATIENT VISITED THE HOSPITAL DUE TO A PAIN IN HER FOOT. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THE BREAKAGE OF THE NAIL AT THE DISTAL SIDE STOPPING HOLE. PER SURGEON THIS NAIL WAS INITIALLY CHOSEN JUDGING FROM THE FEMORAL TROCHANTERIC FRACTURE, BUT A LONGER NAIL SHOULD HAVE BEEN CHOSEN AS THE FEMUR HAS SUB-TROCHANTERIC FRACTURE. DURING THE SURGERY, REDUCTION WAS CAREFULLY PERFORMED WHILE BEING AWARE OF THE PATIENT IN THE VARUS POSITION. RE-OPERATION IS PLANNED TO RE-FIX THE FRACTURE SITE. CONCOMITANT DEVICES REPORTED: TFNA SCREW 80MM ¿ STERILE (PART # 04.038.080S, LOT # 9923801, QUANTITY 1), TFNA END CAP EXTENS. 0 TAN (PART # 04.038.000S, LOT # L301088, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS (PART # 04.005.522, LOT # L360351, QUANTITY 1), EXTRACT-INSTR F/NAILS CANN (PART # 03.037.032, LOT # 9237384, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184042 9MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H050503 07611819651739

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention