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 Burn(s) (1757); 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 12/31/2019

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: 13 events were reported for this quarter.Product return status: 1 device was received.12 device investigation types have not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 devices were found to be affected by bearing corrosion.Additional information: 13 devices were not labeled for single-use.13 devices were not reprocessed or reused.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.7 events had no patient involvement; no patient impact.1 event had no known patient involvement or patient impact.3 events had patient involvement; no patient impact.2 events had the patient receive a burn.

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 events were originally reported for this failure mode during the reporting quarter.- 1 event was inadvertently excluded.- 14 reported events are included in this follow-up record.Product return status 4 devices were received.10 device investigation types have not yet been determined.Event confirmation status 1 reported event was confirmed.3 reported events were not confirmed.Evaluation results 3 devices were found to be affected by corroded bearings? 1 device was found to be affected by compromised lubrication.

Event Description

This report summarizes 14 malfunction events in which the device reportedly overheated.8 events had no patient involvement; no patient impact.1 event had no known impact or consequences to the patient.3 events had patient involvement; no patient impact.2 events had the patient receive a burn.

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 14 previously reported events are included in this follow-up record.Product return status 6 devices were received.2 devices were not available for evaluation.6 device investigation types have not yet been determined.

Event Description

This report summarizes 14 malfunction events in which the device reportedly overheated.- 9 events had no patient involvement; no patient impact.- 1 event had no known impact or consequences to the patient.- 3 events had patient involvement; no patient impact.- 1 event had the patient receive a burn.

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, h10.14 previously reported events are included in this follow-up record.Product return status 6 devices were received.8 devices were not available for evaluation.

Event Description

This report summarizes 14 malfunction events in which the device reportedly overheated.- 7 events had no patient involvement; no patient impact.- 1 event had no known impact or consequences to the patient.- 3 events had patient involvement; no patient impact.- 3 events had the patient receive a burn.

• 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: 9636731
• MDR Text Key: 177374812
• Report Number: 0001811755-2020-00224
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 14
• 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: 12/31/2019
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 12/31/2019; 12/31/2019; 12/31/2019
• Supplement Dates FDA Received: 04/29/2020; 01/28/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1