MAUDE Adverse Event Report: MONTERIS MEDICAL MINI-BOLT SYSTEM

Model Number	21228
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The vue extractor tool is designed to not over-torque the vue mini-bolt to reduce the likelihood of mini-bolt damage.The vue extractor tool in this case worked as intended and stripped out before damaging the mini-bolt.The torque needed to remove the mini-bolt is assumed to be higher than expected.Each extractor tool lot is torque tested to confirm it meets specification.The vue extractor tool is a class i medical device and is exempt from 510(k) premarket notification requirements, therefore, no pma or 510(k) number exists.A letter to file documenting the rationale for not submitting a 510(k) is maintained within the manufacturer's quality management system.This mdr is being submitted to comply with medical device reporting requirements.
Event or Problem Description
At the end of an ablation procedure, it was reported that upon removal of the vue mini-bolt, the vue extractor tool cracked and the vue mini-bolt could not be removed.A second extractor tool was used which also resulted in a crack along the side of the tool.A blue vue adapter was used at the end of the bolt driver but could not remove the bolt and only spun without engaging the bolt.A third extractor tool was used for another attempt to remove the mini-bolt, but it just spun without budging the bolt.At this point, the surgeon had to drill out bone around the bolt in order to remove the bolt.

• Brand Name: MINI-BOLT SYSTEM
• Common Device Name: MINI-BOLT SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: michelle bergstrom ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 23817146
• Report Number: 3009970070-2025-00017
• Device Sequence Number: 9396210
• Product Code: HAO
• UDI-Device Identifier: 00816589021189
• UDI-Public: 00816589021189
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: NONE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 21228
• Device Catalogue Number: CMB-VX
• Device Lot Number: M0516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown