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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2022

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: 9 events were reported for this quarter.Product return status: 4 devices were received.5 device investigation types have not yet been determined.Additional information: 9 devices were not labeled for single-use.9 devices were not reprocessed or reused.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.4 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

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: 5 devices were received.2 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.4 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

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 5 devices were received.3 devices were not available for evaluation.1 device investigation type has not yet been determined.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.- 4 events had no patient involvement; no patient impact.- 2 events had patient involvement; no patient impact.- 3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

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, h10.9 previously reported events are included in this follow-up record.Product return status: 5 devices were received.4 devices were not available for evaluation.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16262011
• MDR Text Key: 308858142
• Report Number: 3015967359-2023-00295
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2023

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 Model Number: 5100015250
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2022
• Initial Date FDA Received: 01/29/2023
• Supplement Dates Manufacturer Received: 12/31/2022; 12/31/2022; 12/31/2022
• Supplement Dates FDA Received: 04/25/2023; 07/27/2023; 10/24/2023
• 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