MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) REFERENCE FRAME - SMALL PASSIVE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9730605
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site declined to provide patient identifier, age and weight, per (b)(6) privacy laws.No parts have been received by manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that, while in a spine fusion procedure, the reference frame screws, holding the frame to the attachment mechanism, were stripped causing the frame to be loose.This was reported to occurred while placing the frame onto the clamp.A second device was brought in to be used in continuing the procedure, no further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was 10 minutes.There was no impact on patient outcome.

• Brand Name: REFERENCE FRAME - SMALL PASSIVE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6356909
• Report Number: 1723170-2017-00764
• Device Sequence Number: 16519780
• Product Code: OLO
• UDI-Device Identifier: 00721902812743
• UDI-Public: 00721902812743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131425
• 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
• Report Date (Section B): 02/24/2017

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: 9730605
• Device Lot Number: 120524
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1