WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE
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Model Number 202.212 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional product codes: hrs, ktt.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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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Event Description
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It was reported patient underwent an open reduction internal fixation (orif) of the ankle on (b)(6) 2018.During the procedure, the surgeon attempted to insert a 2.7mm locking screw into the distal fibular plate, but the locking screw would not grip the threads of the plate.The screw was easily removed and replaced with another 2.7mm locking screw.Surgery was completed with a delay of approximately 5 minutes.No patient consequence was reported.Concomitant devices reported: distal fibular plate (part number unknown, lot number unknown, quantity 1) this report is for one (1) 2.7mm locking screw this is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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