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

Model Number	9733734
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the handle 9733734 ratcheting qc sm strght (lot #: 66301 found physical damage and pieces missing.The end cap had been broken off and was missing.The ratchet mechanism and instrument retention mechanism are both otherwise functional.Product event summary: #s7 damaged ratcheting handle product analysis (b)(4): mnav findings and conclusions: as reported, the end cap has been broken off and is missing.The ratchet mechanism and instrument retention mechanism are both otherwise functional.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 missing.Other relevant device(s) are: product id: 9733856, serial/lot #: (b)(4), udi#: (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 back of the ratcheting handle silver cap came off.This was noticed when inspecting the instrument tray.There was no patient present at the time of the event.

• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8643246
• Report Number: 1723170-2019-02653
• Device Sequence Number: 296281
• Product Code: OLO
• UDI-Device Identifier: 00643169089600
• UDI-Public: 00643169089600
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 9733734
• Device Catalogue Number: 9733734
• Device Lot Number: 66301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 05/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1