(b)(6).(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: october 09, 2015.Expiration date: september 30, 2024.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an expert (ex) humeral nail and two (2) 4.0 mm locking screws were removed from a patient on (b)(6) 2016.The patient underwent a humeral nailing procedure on an unknown date.X-rays taken on (b)(6) 2016 revealed the humeral nail migrated upward because of poor bone quality.The entire construct was successfully removed intact which included one (1) humeral nail, one (1) spiral blade, one (1) end cap and two (2) locking screws.The patient status was stable.There was no reported delay in surgery to remove.Concomitant devices reported: spiral nail (quantity 1) ; end cap (quantity 1); locking screw (quantity 2) this is report 1 of 1 for (b)(4).
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