Without a lot number the device history records review could not be completed.
Product was not returned.
The investigation could not be completed; no conclusion could be drawn, as no product was received.
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.
|
It was reported that on (b)(6) 2020, a helical blade/screw coupling screw had an issue during surgery.
During insertion of the lag screw the coupling screw would disengage and unwind, the surgeon repeatedly had to retighten the connection screw in order to advance the lag screw which he had difficulty inserting as the patient had hard/dense bone and the surgeon did not tap for the lag screw.
Upon post-op images being taken it was noticed that there were two small metal fragments in the patient soft tissue which appear to be some of the threads from the coupling screw.
There was no surgical delay reported.
The surgery was completed successfully.
The patient outcome was successful.
This report is for one (1) helical blade/screw coupling screw.
This is report 1 of 2 for (b)(4).
|