The following information was reported via uf/importer report# (b)(4), received on 14-july-2022: while surgeon was working, needle driver broke in the wound.All pieces found and visualized.X-ray called and 2 views taken and there was no foreign body in wound.Original intended procedure: open reduction internal fixation right distal radius and scaphoid fracture (right) no patient injury, death or surgical delay was reported.Additional information has been requested.
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The carb-bite crile-wood needle hoodler (121132) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; thus, device history record (dhr) was reviewed, and no anomalies related to the reported issue were identified.A definitive root cause of the reported issue could not be determined.The issue of breaking may be the result of rough handling or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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