Catalog Number 3910-500-568 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2019 |
Event Type
malfunction
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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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Event Description
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It was reported that there was debris in the joint.The debris was flushed out of the joint and the procedure was completed successfully.
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Manufacturer Narrative
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Alleged failure: this was reported on 6-20-2019.Surgeon was drilling for 7th iconix 1 anchor at the 11 oclock position of a bankart/slap repair.Bone quality was soft-normal.Went to put iconix anchor in after drilling pilot hole and could not advance anchor into the guide.At that point we noticed there was debris left in the guide from the drill bit.Were able to remove the pieces from the guide and have included those in return packaging.Pieces not included had to be removed from the joint with shaver and suction.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on drill, 2) starting and stopping drill, 3) pulling drill out of bone without running drill, or 4) moving drill guide during drilling.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 there was debris in the joint.The debris was flushed out of the joint and the procedure was completed successfully.
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Search Alerts/Recalls
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