MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC THORACIC PROBE 9734680 NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that during a spine procedure on (b)(6), the thoracic probe was bent, the end twisted from use of the probe with a mallet.There was no impact to the patient and no delay.No additional information was provided.
Additional Manufacturer Narrative
Additional information: the navlock thoracic probe was returned to the manufacturer for analysis.Analysis found that the tip of the prove has been severly twisted.There are also impact marks at the back end of the probe causing "filt" issues with the mating tracker.Analysis found that the reported event was related to a physical damage issue.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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient information updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received stating that the instrument was not verifying.

• Brand Name: THORACIC PROBE 9734680 NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8491511
• Report Number: 1723170-2019-01591
• Device Sequence Number: 1471248
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 180816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 06/13/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 116