MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE 9734403 THORACIC; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734403
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacture date was unavailable on the date of filing.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an instrument being used with a navigation system.It was reported that intra/peri-operatively during a sacroiliac and thoracolumbar procedure, the surgeon bent the thoracic probe.There was no delay to the procedure.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Follow-up with the manufacturer representative (rep) determined that the probe did not pass verification after it was bent and the probe was disposed of so the device could not be analyzed.The rep also appeared to indicate that a different probe was not used for the procedure.

• Brand Name: PROBE 9734403 THORACIC
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8260185
• Report Number: 1723170-2019-00321
• Device Sequence Number: 16177542
• Product Code: OLO
• UDI-Device Identifier: 00763000053802
• UDI-Public: 00763000053802
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: Health Professional
• Device Model Number: 9734403
• Device Catalogue Number: 9734403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 89