PIONEER SURGICAL (D.B.A. RTI SURGICAL) CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES; CERCLAGE FIXATION CABLE
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Model Number 400-897 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This report is a follow-up to an already existing report.The distributor of this product incorrectly as identified theirself as the manufacturer of this device and submitted report number, 2939274-2019-58140, on their behalf.Three follow-up requests were sent from the distributor to the customer in efforts to obtain additional occurrence information.To date no further information was obtained.It remains unknown if a revision surgery took place.Current patient condition remains unknown.The device was not returned to rti surgical for evaluation.A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility.This report will be updated should additional information become available at a later date.
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Event Description
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It was reported to rti surgical on 1/09/2020 that an abnormal radiographic evaluation confirmed a hardware failure approximately 67 days post-operatively.Index surgery was performed on (b)(6) 2019 for an intra-operative femur fracture.It was confirmed on (b)(6) 2019 that a hardware failure took place at the fracture site, as well as angulation of the fracture.Although imaging confirmed a hardware failure, it remains unknown which specific piece of hardware failed as there were nine (9) devices implanted in total.Radiographic images could not be obtained by rti surgical.
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