Patient information is unknown.
Additional procode: hwc.
Device malfunctioned intra-operatively and was not implanted / explanted.
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.
Reporter email address is unavailable.
The investigation could not be completed; no conclusion could be drawn, as no product was received.
A device history records review has been requested.
(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.
|
It was reported that the patient underwent hip surgery on (b)(6) 2018.
During the procedure, the helical blade did not pass through the trochanteric fixation nail system (tfn) on back table when testing the nail prior to insertion into patient.
This resulted in the use of the tfn-advanced proximal femoral nailing system (tfna) intraoperatively.
Postoperatively, the surgery team came to realize that out of the sterile packaging, the set screw was engaged too far into the nail, engaging the locking mechanism in the nail and preventing the helical blade from passing.
The set screw needed to be dialed back a few turns in order the for the blade to pass.
It is unknown if there was surgical delay.
Patient outcome is unknown.
Concomitant devices: tfn helical blade (part: unknown, lot: unknown, quantity: 1), trauma screw (part: unknown, lot: unknown, quantity: 1).
This report is for a 12mm/130 deg titanium (ti) cann troch fixation nail 360mm/right-ster.
This is report 1 of 1 for (b)(4).
|