MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp TPX HANDSWITCH; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Catalog Number	7400-009-000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full udi is not available due to missing lot/serial number.
Event or Problem Description
The sales rep from user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: TPX HANDSWITCH
• 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: allison juday ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 25246432
• Report Number: 3015967359-2026-00364
• Device Sequence Number: 15884139
• Product Code: ERL
• UDI-Device Identifier: 07613327483055
• UDI-Public: (01)07613327483055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• 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): 08/31/2026

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: Other
• Device Catalogue Number: 7400-009-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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