MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRODRILL STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Model Number 5100015250

Device Problem Overheating of Device (1437)

Patient Problems No Patient Involvement (2645); No Information (3190); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2020

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: 7 events were reported for this quarter.Product return status: 3 devices were received.4 device investigation types have not yet been determined.Event confirmation status: 2 reported events were confirmed.1 reported event was not confirmed.Evaluation results: 2 devices were found to be affected by bearing corrosion.Additional information: 7 devices were not labeled for single-use.7 devices were not reprocessed or reused.

Event Description

This report summarizes 7 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.1 event had no information received.

Event Description

This report summarizes 7 malfunction events in which the device reportedly overheated.7 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: b5, h10 7 previously reported events are included in this follow-up record.Product return status 4 devices were received.3 device investigation types have not yet been determined.Event confirmation status 3 reported events were confirmed.1 reported event was not confirmed.Evaluation results 1 device was found to be damaged.3 devices were found to be affected by bearing corrosion.

Event Description

This report summarizes 7 malfunction events in which the device reportedly overheated.7 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: b5, h10 7 previously reported events are included in this follow-up record.Product return status 4 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.

Event Description

This report summarizes 7 malfunction events in which the device reportedly overheated.7 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: 7 previously reported events are included in this follow-up record.Product return status: 4 devices were received.3 devices were not available for evaluation.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 9998440
• MDR Text Key: 191039345
• Report Number: 0001811755-2020-01199
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1