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Device Problems
Difficult to Remove (1528); Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.Date of event: unknown.This report is for two unknown solid titanium tibial nails/unknown lots.Part and lot numbers are unknown; udi number is unknown.Implant date: unknown.Only the right nail was removed during the revision procedure on (b)(6) 2016; the left nail remains implanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reporting the following event: the patient underwent a bilateral removal of a solid titanium tibial nail system on (b)(6) 2016.The nails were migrating into the joint surface and the surgeon decided the remove the hardware once the injury had healed.Due to bony ingrowth, it was very difficult to remove the right nail.As a result, it took approximately one and a half (1.5) hours to take the nail out.The surgeon tried to remove the left nail but decided against it because it would not budge and had left it implanted.Postoperative patient outcome is stable.It is unknown when the patient was implanted with the hardware.This report is for the need for a revision procedure.This complaint is linked with (b)(4) which captures an intra-operative event during the revision procedure.Concomitant devices reported: titanium end cap (part unknown, lot unknown, quantity unknown), titanium locking bolt (part unknown, lot unknown, quantity unknown), titanium locking screw (part unknown, lot unknown, quantity unknown).This report is for two unknown solid titanium tibial nails.This is report 1 of 1 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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Additional information was received on august 24, 2016 further reporting that the allotted surgical time for the procedure was two (2) hours.
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Search Alerts/Recalls
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