Catalog Number XXX-FOREFOOT SET |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
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Event Description
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It was reported that on (b)(6) 2019, some drills of the forefoot set have important traces of residues inside the hollow bodies and there were also traces on supports.
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Manufacturer Narrative
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Failure analysis: due to the unavailability of kits in the warehouse, 2 kits were transferred from one facility to another facility for specific surgery.The sets were neither inspected nor decontaminated by trained integra employees.The standard travel set process was not followed.Dhr: set was not returned to the kitting centre for inspection/ decontamination.Hence dhr does not need to be reviewed.1 of 2 reports.Other mfg report number: 9615741-2019-00010.
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Search Alerts/Recalls
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