MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	9733498
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used during a spinal procedure.It was reported that the needle sheered off at the handle when the surgeon had unlocked the green locking leaver and was twisting to remove.The site had to use cockers around the broken head to clamp onto and rotate out working as a make shift handle.  the blue handle with 4 spheres broke off of the sharp inner shaft.The handle came off  intact, however, the white plastic connected to the sharp inner shaft broke into two (all plastic retrieved) and the broken shaft was sharp.It was immediately emptied into the sharps container.There was no delay in the procedure and no impact on patient outcome.

• Brand Name: N/A
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12009017
• Report Number: 1723170-2021-01609
• Device Sequence Number: 19915695
• Product Code: MAX
• UDI-Device Identifier: 00613994475169
• UDI-Public: 00613994475169
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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 Expiration Date: 01/29/2023
• Device Model Number: 9733498
• Device Catalogue Number: 9733498
• Device Lot Number: 210129E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/16/2021
• 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: 107