MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5 MM FINE DIAMOND, EXTENDED; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5820012315
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the bur was inserted into the drill steel filaments came off the bur.The procedure was completed successfully with no delay, medical intervention, or adverse consequences reported.
Event or Problem Description
It was reported that when the bur was inserted into the drill steel filaments came off the bur.The procedure was completed successfully with no delay, medical intervention, or adverse consequences reported.
Additional Manufacturer Narrative
Correction: h4 manufacturing date additional information: received device lot number.H6: the quality investigation is complete.

• Brand Name: 1.5 MM FINE DIAMOND, EXTENDED
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 20129353
• Report Number: 3015967359-2024-01764
• Device Sequence Number: 7482699
• Product Code: HBE
• UDI-Device Identifier: 04546540467423
• UDI-Public: (01)04546540467423(17)280901(10)23258017
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/28/2025

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: 5820012315
• Device Lot Number: 23258017
• 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: 08/04/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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