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Catalog Number 462.644 |
Device Problem
Unintended Movement (3026)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Exact date of symptom onset and device loosening is unknown.(b)(4).The original implant procedure was performed on an unknown date in (b)(6) 2016.Per facility, the complainant part was discarded and is no longer available for evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that a patient underwent a revision procedure on (b)(6) 2016 due to unintended movement (back out) of a spiral blade from a humeral nail.The patient was originally implanted with hardware earlier in (b)(6) 2016.However, x-rays taken on (b)(6) 2016 revealed that the titanium (ti) end cap had come loose, which resulted in the spiral blade backing out of the solid humeral nail.During the revision, the surgeon repositioned the nail after removing the blade, the end cap, and a locking screw.The nail and end cap were re-used, but a new locking screw and blade were inserted to complete the procedure.There was no reported delay or additional intervention required.The patient was reportedly stable post-operatively.Concomitant device(s) reported: locking screw (part/lot: unknown / quantity: 1) and humeral nail (part: 462.722 / lot: unknown / quantity: 1).This report is 1 of 2 for com-(b)(4).
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Search Alerts/Recalls
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