Catalog Number 04.027.268S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Impaired Healing (2378); No Code Available (3191)
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Event Date 11/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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Patient¿s age is reported approximately in 70s.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Device was reportedly discarded.(b)(6).(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device was 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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Device report from synthes europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2015, patient underwent initial implant procedure.On (b)(6) 2016, the patient was revised from a pfna nail to lfn or blade plate due to non-union.The implant was not broken and the surgeon believes that the patient experienced a non-union related to "bad" fracture and the patient's poor biology-rheumatoid arthritis.No delay in surgery was reported.Patient outcome was reported well one day after revision procedure.This report is for one (1) pfna nail.This is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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Device was 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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Search Alerts/Recalls
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