Patient weight was not provided for reporting.Additional device product code: hwc.Implant date: device remained implanted.Device explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation as device remained implanted.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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, patient underwent procedure for an open reduction internal fixation (orif) olecranon fracture.During the procedure, a locking screw would not lock into the left olecranon plate.The surgeon tried to insert the screw in on power then switched to manual, but was still unsuccessful.The interface between the plate and screw did not lock into the plate.There was a two-minute surgical delay to obtain another of the same screw which was inserted in a different hole in the plate.The plate and ten (10) screws were implanted.The surgery was successfully completed.The patient outcome was as expected.Concomitant devices reported: power screwdriver (part# unknown, lot# unknown, quantity 1).Screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) 2.7mm/3.5mm va-lcp olecranon pl 2h/lt/90mm.This is report 1 of 2 for (b)(4).
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