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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Pressure Increased (4586)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meningioma surgery, the stryker drill bit broke.The drill bit was not immediately found, but significant bleeding was observed in the subdural space, along with an increase in intracranial pressure and the onset of cerebral herniation.The 2 mm drill bit fracture was found opposite a vein and an artery at the end of the right sylvian valley.Hemostasis with bipolar forceps, application of floseal and tachosil, absence of active bleeding at the end of the procedure.Clinical consequence and patient's current condition: right frontotemporal cortical arterial and venous injury with significant bleeding (exact blood loss unknown), prolonged operative time.The procedure was completed successfully.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
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: 20938593
• Report Number: 3015967359-2024-02403
• Device Sequence Number: 12776005
• Product Code: HBE
• UDI-Device Identifier: 04546540362421
• UDI-Public: (01)04546540362421(17)270601(10)24115017
• 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): 06/23/2025

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: 24115017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: Other
• Patient Sex: Unknown