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 Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2019

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: 8 events were reported for this quarter.Product return status: 8 device investigation types have not yet been determined.Additional information: 8 devices were not labeled for single-use.8 devices were not reprocessed or reused.

Event Description

This report summarizes 8 malfunction events in which the device reportedly overheated.5 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.1 event 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 8 events were originally reported for this failure mode during the reporting quarter.9 events should have been reported; 1 event was inadvertently excluded.- 9 reported events are included in this follow-up record.Product return status 1 device was received.2 devices were not available for evaluation.6 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 corroded bearings.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.1 event 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: 9 previously reported events are included in this follow-up record.Product return status: 2 devices were received.5 devices were not available for evaluation.2 device investigation types have not yet been determined.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.5 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.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 corrected data: h10 9 previously reported events are included in this follow-up record.Product return status 2 devices were received.7 devices were not available for evaluation.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.- 5 events had no patient involvement; no patient impact.- 2 events had no known impact or consequences to the patient.- 2 events had patient involvement; no patient impact.

• 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: 9245356
• MDR Text Key: 174908682
• Report Number: 0001811755-2019-03461
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 9
• 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

• 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: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 09/30/2019; 09/30/2019
• Supplement Dates FDA Received: 04/28/2020; 01/28/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1