MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE 9733457 PEDICLE 2.25MM; INSTRUMENT, STEREOTAXIC

Model Number	9733457
Medical Device Problem Codes	Imprecision (1307); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.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 a navigation system being used for a sacroiliac and thoracolumbar procedure.It was reported that if the cervical probe was rotated without moving the tip of the probe, the image would move.Back up products were used to complete the procedure.This issue occurred intraoperatively and did not cause any surgical delay.There was no reported impact on patient outcome.Additional information was received the tip of the probe was bent which made the screen move.It was noted the bent prove was still able to verify.
Additional Manufacturer Narrative
The probe was returned to the manufacturer for evaluation.Analysis found that the probe was visibly bent.When attached to a known operational instrument tracker, the probe displayed a good geometry error but a high divot error due to the malformation.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.

• Brand Name: PROBE 9733457 PEDICLE 2.25MM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9676825
• Report Number: 1723170-2020-00385
• Device Sequence Number: 16853381
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 9733457
• Device Catalogue Number: 9733457
• Device Lot Number: 161128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1