MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp 1.5mm x 10.0mm Tapered Router; Drills, Burrs, Trephines & Accessories (Simple, Powered)

Catalog Number	5820071015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction

• Brand Name: 1.5mm x 10.0mm Tapered Router
• Common Device Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Ireland; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 25907808
• Report Number: 3015967359-2026-99431
• Device Sequence Number: 8411949
• Product Code: HBE
• UDI-Device Identifier: 04546540467690
• UDI-Public: 04546540467690
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 5820071015
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown