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Model Number 475.940 |
Device Problem
Unintended Movement (3026)
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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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Additional narrative: date of device migration is not known.Date of implant reported only as 2011.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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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It was reported that on (b)(6) 2018 a patient underwent hardware removal of a 4.0mm titanium elastic naill due to the device extruding into the knee joint.The patient was originally implanted with two (2) elastic nails on an unknown date sometime around the year of 2011.Following that original procedure, the patient was told to have both of the devices removed for unknown reasons.During the (b)(6) 2018 procedure, one (1) of the two (2) elastic nails were removed (the one extruding into the knee) and an incision and drainage (i&d) was performed on the knee joint.The surgery was successfully completed with no reported surgical delay.The patient was reported to be okay following the procedure.Concomitant device reported: elastic nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.0mm titanium elastic nail 440mm.(b)(4).
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Search Alerts/Recalls
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