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

Model Number 9733498

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

No devices were returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12009017
• MDR Text Key: 256488224
• Report Number: 1723170-2021-01609
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00613994475169
• UDI-Public: 00613994475169
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 107