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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. TACTILE AWL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. TACTILE AWL; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number NONE
Device Problems Bent (1059); Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2014
Event Type  malfunction  
Event Description
A medtronic representative reported that, while in an l3-s1 posterior fusion spine procedure, the site's tactile awl was damaged using sacroiliac screws.When placing the 9.5x90 screw on the patient's left side, the straight tactile awl was bent.The surgeon also tapped line to line with a 9.5 tap.X-ray was used to confirm the screw was placed accurately.There was no impact on patient outcome.
 
Manufacturer Narrative
Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Return requested.Replacement tactile awl shipped to site (b)(4) 2014.No parts have been returned to manufacturer for analysis.
 
Manufacturer Narrative
Although a specific cause of the reported incident was unconfirmed as the part was not returned to the manufacturer, further review of the complaint history by hardware engineering found additional occurrences of the reported issue.The reported physical damage is general and typical of the intended use.The complaints are being monitored through post market monitoring with no further actions required.
 
Manufacturer Narrative
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 it 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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Brand Name
TACTILE AWL
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 Key4228776
MDR Text Key5073303
Report Number1723170-2014-01188
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,Followup,Followup,Followup
Report Date 07/01/2015,02/22/2016
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? Yes
Device Operator Physician
Device Model NumberNONE
Device Catalogue Number9734435
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Report Sent to FDA07/01/2015
Distributor Facility Aware Date06/03/2015
Initial Date Manufacturer Received 06/03/2015
Initial Date FDA Received11/05/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received07/01/2015
09/16/2015
11/09/2015
02/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age53 YR
Patient Weight102
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