Model Number N/A |
Device Problem
Sticking (1597)
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Patient Problem
No Information (3190)
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Event Date 12/20/2013 |
Event Type
Injury
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Event Description
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It was reported patient underwent a ligament reconstruction procedure on (b)(6) 2013.During the procedure, the clear sleeve stuck on the inserter.A cocher and mallet were utilized to deploy the juggerknot and complete the procedure.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
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Manufacturer Narrative
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Examination of returned device found no evidence of product non-conformance.Dimensional evaluation found component to be within appropriate design specification.
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Search Alerts/Recalls
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