MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP, THORACIC, RADIOLUCENT; INSTRUMENT, STEREOTAXIC

Model Number	9733148
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Separate medical device report (mdr) has been filed for the open spine clamp driver.No parts have been returned to the manufacturer for analysis.Device manufacture date was unavailable at the time of filing.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 site had a stripped screw on their spinous process clamp.This issue was noticed intra/peri-operatively during the select patient/acquire scans task.The site said the driver for the clamp had become rounded and may have contributed to the issue.The surgeon was able to tighten the clamp sufficiently for the case.There was no delay to the procedure.There was no reported impact on patient outcome.

• Brand Name: CLAMP, THORACIC, RADIOLUCENT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7954614
• Report Number: 1723170-2018-05075
• Device Sequence Number: 1498676
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• 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): 10/10/2018

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: Health Professional
• Device Model Number: 9733148
• Device Catalogue Number: 9733148
• Device Lot Number: 160324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 113