STRYKER ENDOSCOPY-SAN JOSE FG., NANOTACK SUTURE ANCHOR, 1.4MM W/ FLEX INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number CAT01858 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the anchor broke during procedure.All pieces were retrieved.
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Event Description
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It was reported that the anchor broke during procedure.All pieces were retrieved.
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Manufacturer Narrative
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Alleged failure: nanotack 1.4 flex anchors not following path of drill, in turn there was bending of the anchors.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) guide out of specification, 2) pathology such as schlerotic bone that may thicken the cortical layer.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Search Alerts/Recalls
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