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Catalog Number 459.380 |
Device Problem
Fitting Problem (2183)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Event Description
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Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the tip of tfn is broken at the distal hole, (area of locking bolt).Only the fragmented tip is available for investigation.The other part of nail is abroad (uae).The first implant date was (b)(6) 2014, nail broke postoperatively.Date of revision was (b)(6) 2014 when the mentioned tfn was implanted.In (b)(6) 2015, it was a revision surgery where the small distal part was explanted, the other fragment was left into patient.The patient was treated with a plate.This report is 1 of 3 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional narrative: patient weight unknown.Patient's age unknown at the time of event.Event date: unknown when device broke.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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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Manufacturer Narrative
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Additional narrative: a manufacturing evaluation was completed: the device was received intact.The screw would have no effect on the nail fracture.The tfn nail broke through the proximal part in the area of the primary bone fracture.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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Manufacturer Narrative
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(b)(6).A review of the device history records was performed and no complaint related issues were found.The explant procedure occurred on an unknown day in (b)(6) 2015.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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Manufacturer Narrative
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The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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