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510k: this report is for an unknown pfna nail.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.(b)(4).
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This report is being filed after the review of the following literature article:jimenez diaz, v., canizares, a., martin, a., peinado, m.(2016).Predictive variables of open reduction in intertrochanteric fracture nailing: a report of 210 cases.Injury, int.J.Care injured 47s3,pp.S51-s55.Spain.This study was designed with the aim of establishing radiological variables that can predict the success of an open reduction when nailing intertrochanteric fractures.An observational prospective study was carried out at hospital (b)(6) during a 24 months period, between march 2013 to march 2015.The inclusion criteria consisted of: patients of both genders of any age who suffered an intertrochanteric fracture after any type of mechanism of injury, and who were surgically treated by intramedullary nailing (pfn-a, synthes, (b)(4)).During 24 months the data of 210 patients who had intramedullary nailing intervention using pfn-a (synthes, (b)(4)) was collected.There were 163 females (78%) and 74 males (22%), with an average age of 83 years (sd 8.19).Regarding laterality, distribution of fractures was the same for both lower limbs (50%).In 207 cases (98%) the mechanism of injury was a fall from standing height.In three cases, the mechanism of injury was pedestrian hits by car.There are four major radiological parameters that can predict the need of approaching the fracture site: posterior buttress, calcar disruption, lateral wall disruption and proximal fragment flexion.There were four radiological parameters associated with the need for open reduction: disruption of lateral wall ( p < 0.0000), posterior wall fracture (p < 0.001), calcar (p < 0.004) and malalignment in the axial view ( p < 0.001).The following results were obtained in preoperative assessment: 66% of fractures had calcar disruption, 44% had lateral wall disruption and 48% had posterior wall disruption.In 52% cases the lesser trochanter was a free fragment isolated from the proximal femur; only in 9% it was attached to the proximal fragment.79% of fractures had a varus or valgus deformity and 45% of fractures had flexion or extension of the proximal fragment.After reduction of fracture on the traction table, 84% of fractures had calcar contact, 96% fractures had lateral wall contact, and 97% had posterior wall contact.In 94% of cases varus or valgus deformity was corrected and in 94% of cases, flexion or extension of the proximal fragment was also corrected.After fixation, an anatomical reduction was achieved in 138 cases (66%); 79% of fractures maintained calcar contact, 90% of fractures maintained lateral wall contact and 88% maintained posterior wall contact.Correction of the varus or valgus deformity and the flexion or extension of the proximal fragment was achieved in 92% and 95% respectively.During initial evaluation, the surgeons determined that only 28 cases would require an open reduction.In 21 cases the main reason for believing in carry out an open reduction was the obliquity reverse fracture pattern, followed by posteromedial buttres conminution with free lesser trochanter in 11 cases; these factors were considered by surgeons the most important cause for a failed closed reduction.Following fixation it was then determined that 48 (23%) cases required an open reduction.In 15 cases lack of reduction in the axial view was the precipitating factor of open reduction; in 13 cases it was caused by lack of reduction of the calcar.Other causes for performing an open reduction were lack of reduction of the lateral wall and varus or valgus malalignment of the proximal fragment.Complications during follow-up were present in 43 cases (20%) with two (2) cases of cut-out for open reduction, one (1) case of cut-off for closed reduction and five (5) cases of nonunion (pseudoarthrosis).For nonunions, three (3) of the cases were open reduction and two (2) of the cases were closed reduction.The most frequent complication was pain at entry point of the helical blade in 24 patients (14 %).It was most frequently associated with fractures which present lateral wall disruption.These subtypes of fractures also presented a higher percentage of lateralization of the helical blade (10%) ¿ of these seven (7) cases were open reduction and 17 were closed reduction.A list of ¿other¿ complications were 9 cases were open reduction and 2 cases were closed reduction.There was shortening and varus collapse of the fracture site observed during radiological follow-up at outpatient clinics, than those subtypes with lateral wall intact (6%).Regarding fracture reduction, no differencies regarding development of complications were found between fractures which required an open reduction and these fracture that did not required the same.Impairment of patient autonomy was observed in 18% of cases, being higher in those with more complex fracture patterns.In the cohort of patients mortality was 19% and 36% of cases it occurs during the first month postoperative, due to medical complications.An association with mortality was noted as higher for fractures that required an open reduction with more complex fracture patterns.This report is for three patients who experienced cut out and 11 patients who experienced shortening and varus collapse of the fracture site.This report is for an unknown pfna nail.This is report 1 of 6 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.
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