Patient date of birth and weight were not provided for reporting.
Device was implanted on (b)(6) 2018 and remained implanted.
Device explant date is not applicable.
Device is not expected to be returned for manufacturer review/investigation.
Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.
Additionally, 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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It was reported that on (b)(6) 2018, patient underwent surgery.
During the surgery, while using the hip tfna nail, the surgeon went to take the locking mechanism of the nail down and it wouldn¿t budge.
They were unable to see on the x-rays whether the nail was up or down, so they had to take the blade and nail out and put them back in again.
This time, the locking mechanism moved without a problem.
Due to this, twenty-five (25) minutes were added to the procedure.
The procedure was completed successfully with no harm to the patient.
Concomitant devices reported: helical blade (part# unknown, lot# unknown, quantity 1).
This report is for one (1) 10mm/130 deg ti cann tfna 360mm/right ¿ sterile.
This is report 1 of 1 for (b)(4).
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