MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BIT GUIDE; INSTRUMENT, STEREOTAXIC

Model Number 960-523

Device Problems Material Integrity Problem (2978); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

The unique identifier was not known at the time of the event.No parts have been received by the manufacturer for evaluation.The manufacture date was not known at the time of the event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that  the 3.2 mm k-wire was stuck in the 3.2 mm cannula.When using the 3.2 mm cannula of the universal drill guide (udg) with a 3.2 mm k-wire the k-wire got stuck in the tip of the cannula.Troubleshooting was performed and the tip of the cannula didn't have the same diameter as the rest of the cannula.The probable cause of the reported issue was that the external force on the cannula tip prior surgery caused the issue.The next step was to replace the cannula.There was no reported delay to the procedure.No impact on patient outcome.

• Brand Name: BIT GUIDE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11602679
• MDR Text Key: 243412011
• Report Number: 1723170-2021-00865
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K974161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-523
• Device Catalogue Number: 960-523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 80