SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S, W/2 UB STR #1, BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72203854 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Zip code: (b)(6).
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Event Description
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It was reported that the surgeon noted that as he advanced 1st suturefix anchor through guide handle, a lot of resistance felt.Asked the surgeon to pull out anchor and noted that suturefix anchor was bent/disfigured.Opened another drill, 2nd anchor used, same technique utilised.Anchor went in fine.3rd anchor opened, same technique used.Suturefix anchor again bent as being advanced into drill guide.Asked nurse to clean tip of drill, surgeon re drilled, and tried to use same anchor.Advised not to, as anchor already bent.Opened a 4th anchor and followed same steps as per surgical technique.This time anchor went in without any other incident.No patient injury was reported.
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Manufacturer Narrative
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Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.
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Search Alerts/Recalls
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