BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE L85 TAN

    MDR report key: 10065231 · Received May 18, 2020

    Report

    Report Number
    8030965-2020-03555
    Event Type
    Injury
    Date Received
    May 18, 2020
    Report Date
    May 5, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819652439
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H6: PART NUMBER: 04.038.285S, LOT NUMBER: H863568, PART MANUFACTURE DATE: APRIL 9, 2019, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: APRIL 1, 2029, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE L85 TAN 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 NONCONFORMANCE 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 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. PRODUCT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. 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. (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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT A PATIENT EXPERIENCED POST-OPERATIVE PAIN. ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY FOR PROXIMAL FEMUR WITH THE TFNA BLADE. X-RAYS AFTER THE SURGERY SHOWED THAT THE FRONT WAS EXTRAMEDULLARY TYPE AND THE LATERAL WAS INTRAMEDULLARY TYPE. THE X-RAYS WHICH WERE TAKEN ON (B)(6) 2019, SHOWED THAT THE INTRAMEDULLARY TYPE EMERGED, AND SLIDING WAS CONFIRMED. THE SURGEON THOUGHT THAT THE SLIDING WAS NO PROBLEM. IN (B)(6) 2020, THE PATIENT REPORTED PAIN. ON (B)(6) 2020, THE CUT-OUT WAS CONFIRMED IN A ROUTINE CHECKUP. ON (B)(6) 2020 THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (THA) SURGERY. THE BONE HEAD NECROSIS WAS NOT CONFIRMED. THE PATIENT WAS RECOVERING AFTER THA SURGERY, AND SHE TOOK EVISTA (OSTEOPOROSIS MEDICINE). CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), LOCKING SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), END CAP (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TFNA HELICAL BLADE L85 TAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531308 TFNA HELICAL BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H863568 07611819652439

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention UNK - END CAPS: TFNA| UNK - NAILS: TFNA| UNK - SCREWS: LOCKING