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
No Code Available (3191)
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Event Date 09/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Allegedly, the locking screw on the resection guide adjustment block became stuck during the case and could not be unlocked.This meant that the height of the guide could not be adjusted.In an attempt to unlock the device the surgeon tried to turn the pink height adjustment screw and the end of the hex driver snapped off in the screw.The case could not be performed, so the patient was woken up and the case had to be rescheduled.
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Manufacturer Narrative
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Functional analysis of the adjustment block features found that the pin lockout knob -gray is jammed and the coronal lockout can unscrew from the main body.There were no issues identified with the proximal/distal lockout, medial/lateral adjustment, or the medial/lateral lockout.
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