MAUDE Adverse Event Report: MONTERIS MEDICAL 3.3MM MINI-BOLT VUE

Model Number 21133

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/07/2023

Event Type  Injury  

Event Description

During an ablation procedure, it was reported that a 3.3mm vue mini-bolt was used.When anchoring the vue bolt, the user did a total of 5.5 turns after start of purchase.For vue bolt removal, the user used the blue hex adapter.The blue adapter could not grip and would only spin on top of the vue bolt.Instead, the user tried to use the vue bolt removal end of the removal tool after given specific instructions to prevent torque to the bolt.The removal tool was turned once, then an audible noise was heard on the second turn.The tool was removed from the bolt and the ceramic shards were visible.The bolt was anchored in the left frontal region above the hairline.The vue bolt was placed close to perpendicular to the skull with no more than a 10 degree angle.The user was standing on the right side of the patient facing superiorly reaching across to the left side from above the patient when using the vue end of the tool to remove the vue bolt.The clinical specialist confirmed that the user first attempted to use hemostats around the vue bolt to remove it from the skull, however, it kept slipping.The user then used a small drill to make a few holes around the base of the bolt around one side.Then a curette was used to remove remaining bone.The user was then able to easily remove the vue bolt from the bone without further damage to the bolt.The vue bolt, broken ceramic shards, and hex adapter was sent back to the office for investigation.

Manufacturer Narrative

The vue bolt, fragmented pieces of the bolt, and the hex adapter was returned, and the bolt was observed to be broken on the crown.An investigation was done to investigate potential failure modes of the vue mini-bolt removal.Testing results of the investigation showed that without the application of side loading, the samples were able to withstand higher force during removal.Investigation determined that when the removal tool is not properly seated or aligned on the vue mini-bolt, the multi-bending forces and stress concentricity can cause the bolt-crown to break.There are no additional patient comorbidities reported for this case.

Event Description

During an ablation procedure, it was reported that a 3.3mm vue mini-bolt was used.When anchoring the vue bolt, the user did a total of 5.5 turns after start of purchase.For vue bolt removal, the user used the blue hex adapter.The blue adapter could not grip and would only spin on top of the vue bolt.Instead, the user tried to use the vue bolt removal end of the removal tool after given instructions by monteris clinical specialist to prevent torque to the bolt with the metal end of the tool.The removal tool was turned once, then a noise was heard on the second turn.The tool was removed from the bolt and the ceramic shards were visible.The bolt was anchored in the left frontal region above the hairline.The vue bolt was placed close to perpendicular to the skull with no more than a 10 degree angle.The user was standing on the right side of the patient facing superiorly reaching across to the left side from above the patient when using the vue end of the tool to remove the vue bolt.The user first attempted to use hemostats around the vue bolt to remove it from the skull, however, it kept slipping.The user then used a small drill to make a few holes around the base of the bolt around one side.Then a curette was used to remove remaining bone.The user was then able to easily remove the vue bolt from the bone without further damage to the bolt.The vue bolt, broken ceramic shards, and hex adapter was sent back to the office for investigation.

Manufacturer Narrative

The vue bolt, fragmented pieces of the bolt, and the hex adapter was returned, and the bolt was observed to be broken on the crown.An investigation was done to investigate potential failure modes of the vue mini-bolt removal.Testing results of the investigation showed that without the application of side loading, the samples were able to withstand higher force during removal.Investigation determined that when the removal tool is not properly seated or aligned on the vue mini-bolt, the multi-bending forces and stress concentricity can cause the bolt-crown to break.Additional information from the physician was received on 6-jul-2023, confirming that there were no patient complications reported for this case, and the patient was discharged according to plan.

• Brand Name: 3.3MM MINI-BOLT VUE
• Type of Device: 3.3MM MINI-BOLT VUE
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: jennifer englund ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 17261817
• MDR Text Key: 318446166
• Report Number: 3009970070-2023-00020
• Device Sequence Number: 1
• Product Code: HAO
• UDI-Device Identifier: 00816589021233
• UDI-Public: 00816589021233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21133
• Device Catalogue Number: CMB033-V
• Device Lot Number: 8379601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention