STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 120; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 3520-1340S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Necrosis (1971)
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Event Date 01/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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"it was reported that the patient's left femur was revised due to avascular necrosis.Rep confirmed there are no allegations against the revised implants.A gamma nail, set screw, lag screw, and distal screw were revised.".
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Event Description
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"it was reported that the patient's left femur was revised due to avascular necrosis.Rep confirmed there are no allegations against the revised implants.A gamma nail, set screw, lag screw, and distal screw were revised.".
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Manufacturer Narrative
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The reported event could be confirmed, although the product was not returned however images & revision usage sheet were provided that matches the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the available information it¿s clear that the device was manufactured in 2012 and corelating it with the event date, root cause would be possibly due to but not limited to patient factor (poor bone quality, nonunion, activity and traumatic overload) rather than device related.If device is returned or any further information is provided, the investigation report will be reassessed.
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