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

Catalog Number	9733734
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the instrument handle required replacement.The system then passed the system checkout and was found to be fully functional.The replaced instrument handle was discarded by the site and is not available for analysis.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the instrument handle was broken during sterilization.There was no patient present when this issue was observed.
Additional Manufacturer Narrative
Manufacture date, lot number.Correction: unique device identifier (udi).

• 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: 7895768
• Report Number: 1723170-2018-04889
• Device Sequence Number: 13801584
• Product Code: OLO
• UDI-Device Identifier: 00763000054465
• UDI-Public: 00763000054465
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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
• Device Lot Number: 40073
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1