Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Examination of returned device found no evidence of product non-conformance.Measureable dimensions were evaluated and the found component to be within appropriate design specification.
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Event Description
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It was reported that patient underwent a chondrocyte implant procedure that utilized a soft anchor on (b)(6) 2015.During the procedure, the surgeon noticed the guide sleeve of the soft anchor device was too close to the handle when the sterile pouch of the soft anchor was opened.The surgeon also felt the guide sleeve was loose and opted not to use the soft anchor device.Another soft anchor device was available to complete the procedure without significant delay.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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