Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for unknown quantity of unknown nail.Part#, lot# and udi # is not available.Device was not explanted.Two unsuccessful attempts were made.Device is not expected to be returned for manufacturer review/investigation.(b)(6).This report is for unknown quantity of unknown nail.Pma/510(k) number is not available.(b)(4).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 a patient underwent initial implant procedure in italy after an accident sometimes in 2015.In (b)(6) 2016, patient underwent a first removal surgery for proximal femoral nail antirotate (pfna).They tried to remove the nail and the blade but it was not possible.The implants were left in the patient.On (b)(6) 2016, patient underwent second removal surgery to remove implants.The second attempt was also not successful.Second attempt of removal surgery will be captured under (b)(4).This report is for unknown quantity of unknown nail ¿ attempted to remove during the first revision surgery.This is report 2 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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Event Description
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Patient was reported as active and athletic.
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Search Alerts/Recalls
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