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

Model Number 5100015250

Device Problem Fracture (1260)

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

Event Date 09/30/2020

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: 10 events were reported for this quarter.Product return status: 1 device was received.9 device investigation types have not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results 1 device was found to be affected by a worn collar.Additional information 10 devices were not labeled for single-use.10 devices were not reprocessed or reused.

Event Description

This report summarizes 10 malfunction events in which the device or cutting accessory fractured.9 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

Event Description

This report summarizes 10 malfunction events in which the device or cutting accessory fractured.10 events had no 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: 10 previously reported events are included in this follow-up record.Product return status: 5 devices were received.5 device investigation types have not yet been determined.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 10 previously reported events are included in this follow-up record.Product return status: 6 devices were received.2 devices were not available for evaluation.2 device investigation types have not yet been determined.

Event Description

This report summarizes 10 malfunction events in which the device or cutting accessory fractured.10 events had no 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 10 previously reported events are included in this follow-up record.Product return status 6 devices were received.4 devices were not available for evaluation.

Event Description

This report summarizes 10 malfunction events in which the device or cutting accessory fractured.- 10 events had no patient involvement; no patient impact.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• MDR Report Key: 10748398
• MDR Text Key: 213451833
• Report Number: 0001811755-2020-02843
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,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: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 09/30/2020; 09/30/2020; 09/30/2020
• Supplement Dates FDA Received: 01/29/2021; 04/30/2021; 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