MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PERCUTANEOUS REFERENCE CROSS PIN FRAME; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9732353
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A site representative reported that, while outside of a procedure, the reference frame would not tighten.There was no patient present when this issue was identified.No additional information was provided.

• Brand Name: PERCUTANEOUS REFERENCE CROSS PIN FRAME
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6772298
• Report Number: 1723170-2017-03229
• Device Sequence Number: 725361
• Product Code: OLO
• UDI-Device Identifier: 00613994151179
• UDI-Public: 00613994151179
• Combination Product (Y/N): N
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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: 9732353
• Device Lot Number: 080709
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1