MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RATCHETING HANDLE; INSTRUMENT, STEREOTAXIC

Model Number	9734410
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The handle was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The end cap had been broken from the return handle.Otherwise, the ratchet and part retention mechanisms are intact and functional.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.There was no patient involvement.The ratcheting handle was found to be broken by the sterilization department.The ratchet handle would be replaced.

• Brand Name: RATCHETING HANDLE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10652031
• Report Number: 1723170-2020-02661
• Device Sequence Number: 4283619
• Product Code: HAW
• UDI-Device Identifier: 00763000053796
• UDI-Public: 00763000053796
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: 9734410
• Device Catalogue Number: 9734410
• Device Lot Number: 104236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1