Pma/510k: this report is for an unknown pfna construct/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.
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This report is being filed after the review of the following journal article: hancioglu, s., gem, k., tosyali, h.K., and okcu, g.(2020), clinical and radiological outcomes of trochanteric ao/ota 31a2 fractures: comparison between helical blade and lag screw ¿ a retrospective cohort study, zeitschrift für orthopädie und unfallchirurgie, vol.Xx, pages 1-9 (turkey).The purpose of this study was to compare the clinical and radiological outcomes of ao/ota type 31a2 fractures treated by the use of trochanteric nails either with a blade or a screw.Between may 2007 and may 2014, a total of 65 patients with trochanteric fractures were included in the study.32 were treated with a proximal femoral nail antirotation (pfn-a; synthes, oberdorf, switzerland) (blade group) and remaining the 33 patients were treated with a zimmer natural nail cephalomedullary nail (znn-cmn; zimmer, indiana, usa) (screw group).The mean ages of the patients were 76.01 and 75.82, respectively (p = 0.905).The mean follow-up time was 27.6 months (blade group: 34.2 ± 19.1 months; screw group: 18.6 ± 7.9 months; p < 0.001).Patients were recalled for follow-up at 6 weeks, 3 months, 6 months, the first year, and annually.The following complications were reported as follows: 36 patients died the first year 3 patients treated with a helical blade had poor reduction.5 patients had secondary varus 1 patient had a deep chronic infection, and was admitted for control in the 17th month postoperatively and required surgical removal of the implant and debridement.7 patients had implant backout.Some were treated with reviion surgery.2 patients had cut-outs.Some were treated with reviion surgery.This report is for an unknown synthes pfna long construct.It captures the reported poor reduction, secondary varus and deep chronic infection.This is report 1 of 3 for (b)(4).
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