MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp 2.3mm Tapered Router; Drills, burrs, trephines & accessories

Catalog Number	5407FA2023
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the instrument oscillated abnormally during a craniotomy, resulting in fracture of the milling cutter head and dural injury of the patient.The procedure was completed successfully and a surgical delay of unknown duration was reported.No further information available at this time.
Additional Manufacturer Narrative
H6: a follow up report will be sent when the investigation is complete.

• Brand Name: 2.3mm Tapered Router
• Common Device Name: Drills, burrs, trephines & accessories
• 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: 50173448
• Report Number: 3015967359-2026-00454
• Device Sequence Number: 15521515
• Product Code: HBE
• UDI-Device Identifier: 07613327096729
• UDI-Public: (01)07613327096729(17)280201(10)25037027
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5407FA2023
• Device Lot Number: 25037027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown