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

Catalog Number	9734435
Medical Device Problem Codes	Bent (1059); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A medtronic representative reported that during spinal fusion procedure, the surgeon used a mallet to hammer a awl tactile instrument into the pedicle.It was reported that the surgeon was trying to redirected the instrument while it was in the bone.When the instrument was removed from the pedicle, the tip of the instrument was bent.The procedure was completed with the use of navigation.There was no delay to procedure.No impact on patient outcome.
Additional Manufacturer Narrative
Fda codes updated to reflect current guidelines.If information is provided in the future, a supplemental report will be issued.

• 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: 7162552
• Report Number: 1723170-2018-00025
• Device Sequence Number: 18847906
• Product Code: OLO
• UDI-Device Identifier: 00613994759610
• UDI-Public: 00613994759610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1