WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY®; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33600030 |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
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Event Description
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Allegedly, it was reported that the patient underwent a total ankle replacement surgery.During the procedure the knob to the adjusting guide block locked up and would not move.The surgeon held the blocks in place to make the cuts needed.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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