MAUDE Adverse Event Report: MICRODRILL STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Model Number 5100015250

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 11 events were reported for this quarter.Product return status: 3 devices were received.8 device investigation types have not yet been determined.Event confirmation status: 3 reported events were not confirmed.Evaluation results: 2 devices were found to be affected by internal corrosion.1 device had no problem found.11 devices were not labeled for single-use.11 devices were not reprocessed or reused.

Event Description

This report summarizes 11 malfunction events in which the device reportedly overheated.9 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 11 events were originally reported for this failure mode during the reporting quarter.- 2 events were inadvertently excluded.- 13 reported events are included in this follow-up record.Product return status: 5 devices were received.8 device investigation types have not yet been determined.Event confirmation status: 1 reported event was confirmed.4 reported events were not confirmed.Evaluation results: 3 devices were found to be affected by corroded bearings.2 devices had no problem found.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.- 11 events had no patient involvement; no patient impact.- 2 events had patient involvement; no patient impact.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.- 10 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 13 previously reported events are included in this follow-up record.Product return status 8 devices were received.1 device was not available for evaluation.4 device investigation types have not yet been determined.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.- 10 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 13 previously reported events are included in this follow-up record.Product return status 12 devices were received.1 device was not available for evaluation.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h6 investigation conclusions.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.10 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• MDR Report Key: 10331477
• MDR Text Key: 200620927
• Report Number: 0001811755-2020-01970
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/29/2021

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
• Device Operator: No Information
• Device Model Number: 5100015250
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 06/30/2020; 06/30/2020; 06/30/2020; 06/30/2020
• Supplement Dates FDA Received: 10/30/2020; 01/29/2021; 04/29/2021; 07/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1