WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY®; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33600030 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Visual Disturbances (2140)
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Event Date 07/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the adjustment block screw was lodged in adjustment block and could not be backed out to lock into the coronal guide.The surgeon postponed the case after the patient was already put under anesthesia.No additional patient complications were reported.
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Manufacturer Narrative
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Visual examination of the returned part does not show any overall gross deformation.Upon an initial functional review of the devices, some of the lock outs seemed jammed but were able to be released without any additional aid of lubrication and/or power, and then the adjustment block knobs functioned as intended.Also, the functional evaluation included a review of the coronal guide lockout, in which a coronal guide was able to be locked into place.Therefore, no failure was detected.
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