MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.3MM SPIRAL ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5407FA2023SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi is unknown as the part/ lot number was not reported.H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that a router broke during a procedure.It was also reported that the procedure was completed successfully with no adverse consequences.No further information available at this time.Information regarding medical intervention and surgical delay have been requested from the customer.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
D1: catalogue number added.D4: gtin added.Full udi is not available due to missing lot number.H6: the quality investigation is complete.

• Brand Name: 2.3MM SPIRAL 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 ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 22053582
• Report Number: 3015967359-2025-01028
• Device Sequence Number: 5192376
• Product Code: HBE
• UDI-Device Identifier: 07613327096712
• UDI-Public: (01)07613327096712
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 5407FA2023SP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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