MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp REMB ELECTRIC MICRO DRILL; Drill, surgical, ent (electric or pneumatic) including handpiece

Catalog Number	6400015000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device overheated during procedure.There were no adverse consequences & the procedure was completed successfully.

• Brand Name: REMB ELECTRIC MICRO DRILL
• 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: 23322642
• Report Number: 3015967359-2025-01537
• Device Sequence Number: 21293329
• Product Code: ERL
• UDI-Device Identifier: 07613154938254
• UDI-Public: (01)07613154938254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2026

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
• Device Catalogue Number: 6400015000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 05/13/2026; 08/25/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 05/15/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2015
• 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