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 02/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that the anchor broke during procedure.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Manufacturer Narrative
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Please note that the initial report's type of reportable event was a malfunction for the anchor breaking.However per investigation results, there was no anchor breakage, the anchor was only bent.Therefore this event is not reportable as there was no breaking of the anchor.Alleged failure: during the surgical procedure, all the surgical technique was complied when making the tunnel with a 1.4 bit and its respective guide.After, the nano tack flex anchor was introduced with the suture threads inside the anchor and at the moment of beginning the impact it began to fracture at the tip and to bend and it was not possible to continue inserting the anchor in the hole that had been made with the drill bit and the implant was removed.Another anchorage was used and te same happened.The anchor fractured very easily with impactions with very little force.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) guide out of specification, 2) use of excessive force, 3) 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.
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Event Description
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It was reported that the anchor broke during procedure.Please note that the initial report's type of reportable event was a malfunction for the anchor breaking.However per investigation results, there was no anchor breakage, the anchor was only bent.Therefore this event is not reportable as there was no breaking of the anchor.
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Search Alerts/Recalls
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