BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE L80 TAN

    MDR report key: 7200887 · Received January 17, 2018

    Report

    Report Number
    8030965-2018-50432
    Event Type
    Injury
    Date Received
    January 17, 2018
    Report Date
    December 20, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819652422
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.038.280S, LOT# H201009. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 05, 2016, EXPIRY DATE: SEP 01, 2026. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 80MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS COMPLAINT IS CONFIRMED BASED ON THE REVIEW OF RECEIVED X-RAYS. 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

    REVISION SURGERY WAS PLANNED FOR (B)(6) 2017; HOWEVER IT IS UNKNOWN IF THE PATIENT REVISED ON (B)(6) 2017 AND IF THE DEVICE WAS EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MEDICAL SAFETY OFFICER REVIEWED X-RAYS AND COMPLAINT DESCRIPTION AND STATED THAT IT APPEARS THAT THE CUT-OUT IS ISOLATED TO THE BLADE, LIKELY DUE TO POOR BONE QUALITY AND PROGRESSIVE COMPRESSION OF FEMORAL HEAD. THE REMAINDER OF THE CONSTRUCT DOES NOT APPEAR TO HAVE MALFUNCTIONED, NOR CONTRIBUTED TO THE CUT-OUT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    UPDATED CONCOMITANT DEVICES: LOT NUMBERS ADDED. 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 THAT A PATIENT UNDERWENT THE ORIGINAL SURGERY TO TREAT THE FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2017. X-RAYS WERE TAKEN DURING THE HEALING PERIOD, THREE WEEKS THROUGH TWO MONTHS, AFTER THE INITIAL SURGERY. AFTER OBSERVATIONS OF THE X-RAYS, IT WAS CONFIRMED THAT THE REDUCTION AREA HAD SHIFTED. CUT-OUT WAS NOTICED THREE MONTHS AFTER THE SURGERY. AN EXPLANT SURGERY IS PLANNED WITH TOTAL HIP ARTHROPLASTY ON (B)(6) 2017. SURGEON COMMENTED THAT THE ORIGINAL REDUCTION WAS THE DISSECTION TYPE, WHICH COULD HAVE BEEN ATTRIBUTABLE TO THE SHIFT AND THE EXTRAMEDULLARY TYPE WAS IDEAL. CONCOMITANT DEVICE REPORTED: 12MM/125 DEG TI CANN TFNA 170MM - STERILE (PART # 04.037.212S, LOT # UNKNOWN, QUANTITY 1), TI END CAP FOR TFNA 0MM EXTN - STERILE (PART # 04.038.000S, LOT # UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STERILE (PART # 04.005.522S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 80MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: 12MM/125 DEG TI CANN TFNA 170MM - STERILE (PART # 04.037.212S, LOT # H027197, QUANTITY 1), TI END CAP FOR TFNA 0MM EXTN - STERILE (PART # 04.038.000S, LOT # L312285, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STERILE (PART # 04.005.522S, LOT # L013988, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46022 TFNA HELICAL BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H201009 07611819652422

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention