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.This report is for an unknown - nail head elem: tfna helical blade /unknown lot number.Without the specific part number, the udi number and 510k 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.
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Device report from synthes reports an event in korea, south as follows this report is being filed after the review of the following journal article: lee h.L., et al (2021) clinical and radiologic outcome of intertrochanteric fracture treatment using tfna (trochanteric fixation nail-advanced), j korean fract soc.Volume 34(3), pages 105-111 (korea, south).This retrospective study aims to examine the clinical and radiological results of the post-treatment of intertrochanteric fractures and considered the implant stability due to a retrospective analysis of the adverse effects of the surgical and radiological findings.From january 2019 to november 2019, 64 patients who visited our hospital for a single intertrochanteric fracture of the femur and operated using tfna (trochanteric fixation nail-advanced; depuy synthes, warsaw, in, usa) were analyzed.Among them, 50 patients were our subjects.Out of 50 cases, 12 males and 38 females were identified.Their average age was 79.04±9.37 years (range 55-97), and the average follow-up period was 13.26±1.55 months (range 12-16 months).5 of the 50 cases of the study died and were excluded during follow-up.Out of 50 cases, 3 developed complications of femur head preformation (cut through 2 cases, cut out 1 case), which was followed by hip prosthetic joint replacement, taking into account age and low activity.Implant-related complications: 3 cases of bone perforation.Two of three cases with bone perforation had been valus reduced, and 1 case was anatomically reduced but with severe osteoporosis (bmd ¿ 3.5) and bipolar prosthetic replacement.4 cases of upper hip outer pain.The change in lateral sliding distance was average 3.95 ± 3.69 mm (range 0.50-18.54 mm)), and the blade¿s migration within the femoral head was average 0.84 ± 0.98 mm (range 0.48-3.2 mm).The adequacy of the position of the blade was analyzed through the comparison of the post-operative neck-shaft angle of the unaffected femur and that of the affected femur and using the post-operative cleveland index and tip-apex distance (tad): tad was observed as an average 19.93 ± 4.30 mm (range 10.15-25.41 mm)).Mm), and in all cases, the attachment of the spiral blade was within 25 mm and was located in zone 4, 5, 6, 8 in all cases in cleveland index.For cleveland index, 4 was observed in 1 case, 5 in 33 cases, 6 in 7 cases , and 8 9 cases.The sliding distance of the spiral blade with 3.64mm in the stable group and 4.19mm in the unstable group, and there were big sliding distance of the column blade but without statistical significance.Fig.3 pelvis anteroposterior radiographs of the right hip of an 81-year-old female.(a) preoperative radiographs show an intertrochanteric fracture (ao/ota 31-a2.2).(b, c) immediate postoperative radiograph after fixation, fish mouth phenomenon*.(d) two-month follow-up x-ray shows the penetration of the blade out of the femoral head, fixation failure.(e) revision to bipolar hemiarthroplasty and returned to walking independently.*fish mouth phenomenon: nailing in a comminuted fracture in the greater trochanter might cause the fish mouth phenomenon, which results in varus angulation and shortening that can progress to fixation failure.This report is for unknown synthes tfna (trochanteric fixation nail-advanced).This is report 2 of 4 for complaint (b)(4).
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