MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820103015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.It was also reported there were no immediate clinical consequences.Piece not found to date, despite several intra-operative and post-operative operation.A request was made for brain scan to verify absence in surgical site.Currently we are making attempts to get additional information from the reporter.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
No new information.

• Brand Name: 1.5MM WIRE PASS DRILL BIT
• 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: 21479653
• Report Number: 3015967359-2025-00476
• Device Sequence Number: 3957287
• Product Code: HBE
• UDI-Device Identifier: 04546540362421
• UDI-Public: (01)04546540362421(17)271001(10)24239017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5820103015
• Device Lot Number: 24239017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown