MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) RATCHETING SMALL STRAIGHT HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9733734
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.Initial reporter unavailable from the site at the time of filing.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been returned to the manufacturer for analysis.
Event or Problem Description
Medtronic received information that while using the system for a procedure, the navlock handle was malfunctioning.There was no reported delay to the procedure due to this issue.
Additional Manufacturer Narrative
Correction: initial reporter updated to proper value.

• Brand Name: RATCHETING SMALL STRAIGHT HANDLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7869391
• Report Number: 1723170-2018-04581
• Device Sequence Number: 19310635
• Product Code: OLO
• UDI-Device Identifier: 00763000054465
• UDI-Public: 00763000054465
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• 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,Followup
• Report Date (Section B): 09/17/2018

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 Catalogue Number: 9733734
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR