MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TAP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734296
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The tap was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.As reported, the tip of the returned tap has been bent.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 outside of a procedure.It was reported that the tip of the tap was bent.It was noted that the cause of the bend was unknown.There was no patient present when this issue was identified.

• Brand Name: TAP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11139708
• Report Number: 1723170-2021-00052
• Device Sequence Number: 677043
• Product Code: OLO
• UDI-Device Identifier: 00613994724113
• UDI-Public: 00613994724113
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: 9734296
• Device Catalogue Number: 9734296
• Device Lot Number: 170207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1