BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS: PFN

    MDR report key: 15094857 · Received July 25, 2022

    Report

    Report Number
    8030965-2022-05142
    Event Type
    Injury
    Date Received
    July 25, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. 510K: THIS REPORT IS FOR AN UNKNOWN NAILS: PFN/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FAN J., ET AL (2021) RISK FACTORS FOR IMPLANT FAILURE OF INTERTROCHANTERIC FRACTURES WITH LATERAL FEMORAL WALL FRACTURE AFTER INTRAMEDULLARY NAIL FIXATION, INJURY VOLUME 52, PAGES 3397¿3403 (CHINA). THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FAN J., ET AL (2021) RISK FACTORS FOR IMPLANT FAILURE OF INTERTROCHANTERIC FRACTURES WITH LATERAL FEMORAL WALL FRACTURE AFTER INTRAMEDULLARY NAIL FIXATION, INJURY VOLUME 52, PAGES 3397¿3403 (CHINA)FROM JANUARY 2006 TO DECEMBER 2018, 130 INTERTROCHANTERIC FRACTURE PATIENTS WITH LFW FRACTURE WERE INCLUDED IN THIS STUDY. THE MEAN AGE OF TOTAL PATIENTS WAS 76 YEARS OLD. OF THESE PATIENTS, 56 WERE MALE PATIENTS AND 74 WERE FEMALE PATIENTS. IN PRESENT STUDY, DIFFERENT NAILING SYSTEMS AND IMPLANT MATERIALS WERE USED: GAMMA 3 (STRYKER, (B)(4), PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA, SYNTHES USA, (B)(4)), TRIGEN INTERTAN NAIL (SMITH & NEPHEW, INC., MEMPHIS, USA), PROXIMAL FEMORAL NAIL (PFN, SYNTHES USA, (B)(4)) 0/1 TRIGEN TAN NAIL (SMITH & NEPHEW, INC., (B)(4)) . THE MEAN FOLLOW- UP WAS 7.5 MONTHS (RANGE: 1 TO 36 MONTHS). REPORTED COMPLICATIONS: FAILURE RATE: PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) 9/71. FAILURE RATE; PROXIMAL FEMORAL NAIL (PFN) 0/1. THIS REPORT IS FOR UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA, AND UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747129 UNK - NAILS: PFN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention