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

Catalog Number 5100015250

Device Problem Overheating of Device (1437)

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

Event Date 12/31/2023

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 19 events were reported for this quarter.Product return status 5 devices were received.4 devices were not available for evaluation.10 device investigation types have not yet been determined.Additional information 19 devices were not labeled for single-use.19 devices were not reprocessed or reused.

Event Description

This report summarizes 19 malfunction events in which the device reportedly overheated.- 10 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.- 3 events had insufficient information received.- 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: b5, h6, h11 19 previously reported events are included in this follow-up record.Product return status 8 devices were received.8 devices were not available for evaluation.3 device investigation types have not yet been determined.

Event Description

This report summarizes 19 malfunction events in which the device reportedly overheated.11 events had no patient involvement; no patient impact.4 events had patient involvement; no patient impact.2 events had insufficient information received.2 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: b5, h6, h10 19 previously reported events are included in this follow-up record.Product return status 5 devices were received.5 devices were not available for evaluation.9 device investigation types have not yet been determined.

Event Description

This report summarizes 19 malfunction events in which the device reportedly overheated.- 11 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.- 2 events had insufficient information received.- 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: 18557624
• MDR Text Key: 333467476
• Report Number: 3015967359-2024-00307
• 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: 19
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2023
• 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