Model Number NONE |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/12/2015 |
Event Type
malfunction
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Event Description
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A medtronic representative reported a site's 5.5 tap that had bone stuck in the cannulated portion of that tap.Site sterile processing staff were unable to remove the bone using a guide wire or sonication.This instrument was part of a loner tray and replacement was requested.There was no patient present when this issue was identified.
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.Return requested.Replacement tap 5.5 shipped to site (b)(4) 2015.Medtronic investigation of returned suspect tap 5.5 finds that, as reported, the tap is blocked with what appears to be bone matter.Physical damage - occluded mechanism.
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Manufacturer Narrative
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The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
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Manufacturer Narrative
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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Manufacturer Narrative
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Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An its solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.
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Search Alerts/Recalls
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