MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; INSTRUMENT, STEREOTAXIC

Model Number	9734410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the handle 9734410 ratcheting egg (lot #: 80018) found that the end cap has been broken off.Otherwise, the tool retention mechanism and the ratchet mechanism both function normally.Product event summary #broken blue egg ratcheting handle product analysis #(b)(4): mnav findings and conclusions: as reported, the end cap has been broken off.Otherwise, the tool retention mechanism and the ratchet mechanism both function normally.Mnav methodology: functional testing;visual/physical examination.Mnav detail: awaiting field response/info mnav usability: false.Mnav able to duplicate the issue?: yes.Mnav bai/oobf?: false.Mnav failure mode: physical damage.Mnav failure mechanism: pieces broken.Other relevant device(s) are: product id: 9733858, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the hammerable part on the back of the handle was broken.This issue could not be linked to a specific surgery or sterilization process.There was no patient present at the time of the event.

• Brand Name: N/A
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8642789
• Report Number: 1723170-2019-02640
• Device Sequence Number: 16706174
• Product Code: HAW
• UDI-Device Identifier: 00613994724007
• UDI-Public: 00613994724007
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 9734410
• Device Catalogue Number: 9734410
• Device Lot Number: 80018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1