MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp 4.0MM BARREL STRAIGHT FLUTE; Drills, burrs, trephines & accessories

Catalog Number	5820018040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a a ventral decompression of the cervical spine with discectomy procedure, the bur broke.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.

• Brand Name: 4.0MM BARREL STRAIGHT FLUTE
• 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 ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; +353()214532900
• MDR Report Key: 23770766
• Report Number: 3015967359-2025-01716
• Device Sequence Number: 9743317
• Product Code: HBE
• UDI-Device Identifier: 04546540467522
• UDI-Public: (01)04546540467522(17)280108(10)25209017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• 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
• Report Date (Section B): 09/14/2026

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: 5820018040
• Device Lot Number: 25209017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2025
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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
• Patient Sex: Unknown