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

Catalog Number	961-576
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A manufacturer representative reported that, while in a spinal fusion, the clamp was found to be damaged.It was reported that a second clamp was used to complete the procedure.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Lot# 160505.Mfg date 2016-05-05.The spine clamp was returned for analysis; as reported, the adjustment screw had been broken off inside the clamp.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. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7354595
• Report Number: 1723170-2018-01194
• Device Sequence Number: 1103405
• Product Code: OLO
• UDI-Device Identifier: 00721902467738
• UDI-Public: 00721902467738
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: Physician
• Device Catalogue Number: 961-576
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1