MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp ESSX HANDPIECE; drill, surgical, ent (electric or pneumatic) including handpiece

Catalog Number	5290601200
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer sales representative reported that the device overheated during a procedure at the user facility.There was no patient involvement.The procedure was completed successfully without a surgical delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
No updates to report.
Additional Manufacturer Narrative
This event is not reportable.

• Brand Name: ESSX HANDPIECE
• Common Device Name: drill, surgical, ent (electric or pneumatic) including handpiece
• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 25164804
• Report Number: 3015967359-2026-00332
• Device Sequence Number: 16093736
• Product Code: ERL
• UDI-Device Identifier: 04546540517593
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5290601200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown