MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SOLERA STD MAST SCREWDRIVER; INSTRUMENT, STEREOTAXIC

Model Number	9734856
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The instrument was not returned, so no analysis has been conducted.Device manufacturing date is unavailable.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.The issue occurred intraoperatively and delayed the surgery by less than one hour.It was reported that the patient had prior hardware in from l1-s1 and needed to be decompressed and sagittally realigned.During the surgery, the solera driver broke while trying to place a screw in very sclerotic bone.The site was able to remove the driver and the broken piece from the wound, find another navigated driver, and properly place the screw without harm to patient.No broken pieces remained in the patient.It was also reported that the solera screw driver was used to get the old screws out but the bone was sclerotic and the driver broke.The broken piece was retrieved successfully from the wound and nothing remained in the patient.The surgery was completed with navigation and there was no impact on patient outcome.

• Brand Name: SOLERA STD MAST SCREWDRIVER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8764750
• Report Number: 1723170-2019-03955
• Device Sequence Number: 1590798
• Product Code: HAW
• UDI-Device Identifier: 00643169045040
• UDI-Public: 00643169045040
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/05/2019

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: No Information
• Device Model Number: 9734856
• Device Catalogue Number: 9734856
• Device Lot Number: 130727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1