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Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown - ria/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.(b)(4).
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This report is being filed after the review of the following journal article: streubel, p., desai, p., and suk, m.(2010), comparison of ria and conventional reamed nailing for treatment of femur shaft fractures, injury, international journal of the care of the injured, vol.41, pages s51-s56 (usa).The purpose of this study is to do an exploratory evaluation of the incidence of pulmonary and healing complications of patients undergoing intramedullary nailing of femoral shaft fractures after either conventional or rinsing-suction reaming.Between january 2005 and september 2006, a total of 156 patients (male to female ratio was 3:1) with an average age of 32 years old were included in this study.All consecutive patients older than 18 years of age that underwent reamed im nailing for a femoral shaft fracture occurring 1cm distal to the lesser trochanter or =6cm proximal to the distal articular surface were included.There were 66 (68 fractures) patients treated with conventional reaming (group a) and 90 patients (97 fractures) treated with the ria (group b).The mean follow-up was 6 months.Mean follow-up for this subset of patients was 251 days (range 42¿703 days) for group a and 248 days (range 47¿640 days) for group b.The following complications were reported as follows: reoperation was necessary in 7% of group a and 8% of group b.The most frequent procedures were nail dynamization (2 and 3 cases respectively), exchange nailing (1 and 2 cases respectively) and painful hardware removal (1 case respectively).Sequential (group a): 7 pulmonary complications, 5 pneumonia, 3 ards/ventilatory failure, 2 delayed union, 1 non-union.Ria (group b): 14 pulmonary complications, 7 pneumonia, 8 ards/ventilatory failure, 3 cases (3%) of infection were found in group b (2 superficial, 1 deep), 5 delayed union, 3 non-union.4 deaths: ria.(b)(6)-year-old man died secondary to ards.He was admitted with an iss of 29 after a motorcycle collision (mcc).Apart from a left midshaft femur fracture he had a right intertrochanteric femur fracture, a left fibula fracture, l2, l4 and l5 vertebral body fractures, a left scapula and clavicle fracture and multiple rib fractures.He sustained a closed head injury with a gcs of 15 at admission.Initial im fixation was attempted in the first 24 hours after admission, but was interrupted and delayed due to physiologic instability after intramedullary reaming.After delayed locking of the index nail, he further underwent plate fixation of the contralateral intertrochanteric fracture.During 25 days of icu care and mechanical ventilation the patient developed ards, pneumonia and anoxic brain injury.(b)(6)-year-old woman whose cause of death was attributed to ards.She was admitted with an iss of 29 and a gcs of 15 after a motor vehicle collision (mvc).Her injuries included a closed left segmental femur shaft fracture, t7, l3 and l4 compression fractures, a stable pelvis fracture and 7th and 8th rib fracture.Comorbidities were limited to arterial hypertension.She underwent im nailing in the first 24 hours after admission.Her pulmonary status fatally deteriorated on hospital day two.(b)(6)-old female with a history of cocaine abuse and hiv.Gcs and iss at admission were 15 and 9 respectively after an mvc.Her injuries included a left midshaft femur and open patella fracture, a right talar neck fracture and subtalar dislocation.She underwent im nailing of the femur, subtalar dislocation reduction and spanning external fixation of the ankle as well as debridement and irrigation of her knee during the index procedure performed within 24 hours after admission.Two days after surgery she developed ards and died 4 days later.(b)(6)-year-old woman who sustained a proximal femoral shaft fracture after a fall.Her comorbidities included ischemic heart disease, alzheimer¿s disease, arterial hypertension and emphysema.No other injuries were present and her iss and gcs at admission were 14 and 9 respectively.She underwent early femoral shaft nailing requiring postoperative icu monitoring and mechanical ventilation.After 16 days she died secondary to ards and multiorgan-system failure.This report is for a titanium cannulated retrograde/antegrade femoral nail ¿ rafn, titanium trochanteric fixation nail -tfn, titanium cannulated lateral entry femoral nail ¿ lfn, reamer¿irrigator¿aspirator ¿ ria, flexible reamer set.(synthes).This report captures group a.This report is 4 of 5 for (b)(4).
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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.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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