MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	961-576
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 outside of a procedure.It was reported that the site had a broken instrument that needed replacement.The screw thread was defragmented and loose on the suretrak small clamp.There was no patient involvement.
Additional Manufacturer Narrative
The clamp, 9733148, thoracic, radiolucent acc 961-576 suretrak2, small clamp (lot# 150110) was returned for analysis.Through functional testing and visual/physical examination analysis found no fault with the clamp.The returned clamp was found to be in good condition and had full function.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8468031
• Report Number: 1723170-2019-01451
• Device Sequence Number: 13933264
• Product Code: OLO
• UDI-Device Identifier: 00721902467738
• UDI-Public: 00721902467738
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 961-576
• Device Catalogue Number: 961-576
• Device Lot Number: 150110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1