Without a lot number the device history records review could not be completed.
Product was not returned.
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.
This complaint will be accounted for and monitored via post market surveillance activities.
If additional information is made available, the investigation will be updated as applicable.
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, during a revision surgery of a trochanteric femoral nailing advanced (tfna) system, the surgeon had difficulty locking the tfna screw to the nail.
The surgeon inserted the lag screw to the nail and locked the set screw in the nail.
Then when he tried to rotate the lag screw, he was only able to rotate it 180 degrees.
The steps were repeated, and the set screw was finally locked.
It is unknown if there were any surgical delays.
The procedure was successfully completed.
The patient outcome is unknown.
Concomitant devices reported: locking screw (part# 04.
005.
528s, lot# unknown, qty 1); tfna screw 95mm (part# 04.
038.
095s, lot# unknown, qty 1); this report is for one (1); 10mm/130 deg ti cann tfna 170mm - sterile.
This is report 1 of 1 for (b)(4).
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