MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERC REFERENCE FRAME; INSTRUMENT, STEREOTAXIC

Model Number	9735141
Medical Device Problem Codes	Imprecision (1307); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Missing device manufacture date.No parts have been returned to the manufacturer for analysis.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 for a sacroiliac and thoracolumbar procedure.It was reported that the small perc pin tracker reference frame ¿jumped¿ after a spin.The reference frame was not bumped and the teeth were fully seated upon the start of the spin.The site did an additional spin.Afterwards, it was found that the teeth were very worn and easily movable.The site was taken out of circulation.There was no patient impact reported and a less than one hour delay to surgery.

• Brand Name: PERC REFERENCE FRAME
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8195118
• Report Number: 1723170-2018-06403
• Device Sequence Number: 1653087
• Product Code: HAW
• UDI-Device Identifier: 00613994151179
• UDI-Public: 00613994151179
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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: 9735141
• Device Catalogue Number: 9735141
• Device Lot Number: 120523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 95