Event date: unknown date in 2019.
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.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had a radial nerve paralysis as confirmed by the facility.
Initially, the patient was implanted with a multiloc humeral nail in question on (b)(6) 2019.
There were four (4) multiloc screws used in the proximal locking and three (3) locking screws used on the distal locking.
The facility plans a reoperation on (b)(6) 2019 and in the reoperation, a large skin incision will be made and necessary procedures will be done according to the condition of the nerve pathways.
This report is for one (1) 4.
0 mm ti locking screw w/t25 stardrive 24 mm f/im nails-ster.
This is report 3 of 8 for (b)(4).
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