MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL

Catalog Number 5100015252

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2023

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 3 events were reported for this quarter.Product return status 1 device was received.2 device investigation types have not yet been determined.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.1 event had insufficient information received.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 3 previously reported events are included in this follow-up record.Product return status: 1 device was received.1 device was not available for evaluation.1 device investigation type has not yet been determined.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.1 event 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 3 previously reported events are included in this follow-up record.Product return status 2 devices were received.1 device was not available for evaluation.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.- 2 events had no patient involvement; no patient impact.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

• Brand Name: MICRO DRILL SERIES ANGLED 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: 17993050
• MDR Text Key: 326369365
• Report Number: 3015967359-2023-02350
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540391803
• UDI-Public: 04546540391803
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 5100015252
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2023
• 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