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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); Discomfort (2330); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(6).This report is for one unknown helical blade.Part and lot numbers were not available for reporting.Other number¿udi: part number is unknown, udi is unavailable.The reported device was revised but not explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Date of manufacture is unknown.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 is reported patient was implanted with the proximal femoral nailing system (tfna) on unknown date at a different facility by a different surgeon for compression of a femoral head fracture.As the fracture compressed over time, the helical blade began to protrude beyond the bone, causing the patient discomfort.Patient was returned to surgery on (b)(6) 2016 for retraction of the helical blade.As surgeon was completing final tightening on the helical blade, it is reported he felt some resistance, and then turned the helical blade extractor one more turn.In doing so, the tip of the helical blade extractor broke off into the end of the helical blade.The fragment was not retrieved and remains embedded in the implanted helical blade.Helical blade was not retracted.The surgery was completed successfully with no delay and no further harm to patient.The helical blade extractor breakage is addressed in related complaint (b)(4).This complaint addresses the retraction of helical blade procedure.Concomitant devices reported: proximal femoral nail (tfna), (quantity 1).This report is for one unknown helical blade.This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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