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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734300
Device Problems Device Reprocessing Problem (1091); Complete Blockage (1094); Occlusion Within Device (1423); Device Issue (2379)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A medtronic representative reported bone stuck inside a solera 5.5 tap.Drill bit was broken off in the tap while attempting to remove the material.There was no patient present when this issue was identified.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Rma issued.Replacement tap 5.5 shipped to site (b)(4) 2014.Medtronic investigation of returned suspect device finds that, as reported, the tip of the instrument has been broken off and is blocked with bony material.Mechanical failure, pieces broken, directly caused event.
 
Manufacturer Narrative
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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Brand Name
5.5MM TAP (CANNULATED)
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek circle
louisville CO 80027 9710
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC.
826 coal creek circle
louisville CO 80027 9710
Manufacturer Contact
kristianna bilan
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key3870226
MDR Text Key20783809
Report Number1723170-2014-00641
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 11/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Medical Equipment Company Technician/Representative
Device Catalogue Number9734300
Device Lot Number131209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/16/2014
Initial Date FDA Received06/12/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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