MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RATCHETING EGG HANDLE; INSTRUMENT, STEREOTAXIC

Model Number	9734410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that ratcheting handle broken, customer ordered the new handle through customer service.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from a user facility regarding a navigation instrument being used for a sacroiliac and thoracolumbar procedure.The caller indicated that the ratcheting egg handle broke during the procedure.The caller indicated that the likely cause was that the ratchet was too big or the center part of the handle was not strong enough.The handle was replaced and there was no delay or impact to patient outcome.
Additional Manufacturer Narrative
The ratcheting egg was returned to the manufacturer for analysis.Analysis found the end cap had been broken from the handle.The instrument was otherwise functional.Analysis found that the reported event was related to a physical damage issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RATCHETING EGG HANDLE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8606044
• Report Number: 1723170-2019-02327
• Device Sequence Number: 14046393
• Product Code: HAW
• UDI-Device Identifier: 00613994724007
• UDI-Public: 00613994724007
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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 Model Number: 9734410
• Device Catalogue Number: 9734410
• Device Lot Number: 104233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 100