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

Catalog Number	9734435
Medical Device Problem Codes	Bent (1059); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested.Replacement tactile awl shipped to site (b)(6) 2016.Medtronic investigation of returned suspect tactile awl finds that, as reported, the tip of the probe is visibly bent.Failure: physical damage hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.No further issues have been reported.
Event or Problem Description
A medtronic representative received a report from a site that while in a spine procedure, when placing an iliac screw, the surgeon bent the tactile awl.No further details regarding this issue, or specifically when it occurred, were provided.A second awl was brought in to continue the procedure to completion with the use of navigation.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: TACTILE AWL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6230807
• Report Number: 1723170-2017-00044
• Device Sequence Number: 13730833
• Product Code: OLO
• UDI-Device Identifier: 00613994759610
• UDI-Public: 00613994759610
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 9734435
• Device Lot Number: 160322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 92