MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BASE, 9732520, QUICK RELEASE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9732520
Medical Device Problem Codes	Device Inoperable (1663); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Site dr.(b)(4).Declined to provide patient information.Device lot number unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.On 04/24/2017 a medtronic representative, following-up at the site, reported the quick release base interfered with a fixation pin and thus could not be detached.Return requested.Replacement quick release base shipped to site 04/06/2017.No parts have been received by manufacturer for analysis.Part not received by manufacturer.
Event or Problem Description
A medtronic representative reported that, while in a spine procedure, the site stated that the pin could not be removed from their quick release base.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
Additional Manufacturer Narrative
Additional information: device lot number and manufacture date provided.The suspect quick release base was returned to the manufacturer for evaluation.Testing found one pin stuck to the base.The link had seized and the pin would not release.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: BASE, 9732520, QUICK RELEASE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6546581
• Report Number: 1723170-2017-01808
• Device Sequence Number: 13473566
• Product Code: HAW
• UDI-Device Identifier: 00613994123565
• UDI-Public: 00613994123565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030552
• 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): 06/06/2017

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: 9732520
• Device Lot Number: 150727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1