Catalog Number 14-500052 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2018-00717, 3012447612-2018-00718, and 3012447612-2018-00729 thru 3012447612-2018-00731.
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Event Description
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It was reported that five cables were broken during installation while tension was being applied.The cables were removed and replaced without reported patient impacts.This is report four of five for this event.
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Manufacturer Narrative
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The returned double cable was evaluated.Visual inspection revealed that the cable has broken.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.It is possible that the surgeon over tensioned the cable during installation as was reported by the sales representative.
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Event Description
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It was reported that five cables were broken during installation while tension was being applied.The cables were removed and replaced without reported patient impacts.This is report four of five for this event.
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Search Alerts/Recalls
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