MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.2MM CROSS-CUT FISSURE; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820066012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported via health canada report reference #(b)(4), that during a surgical procedure, the drill bit broke at the tip.No further information was provided.
Event or Problem Description
It was reported via health canada report reference # (b)(4), that during a surgical procedure, the drill bit broke at the tip.No further information was provided.
Additional Manufacturer Narrative
The quality investigation is complete.

• Brand Name: 1.2MM CROSS-CUT FISSURE
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16672544
• Report Number: 3015967359-2023-00662
• Device Sequence Number: 15064293
• Product Code: HBE
• UDI-Device Identifier: 04546540362346
• UDI-Public: 04546540362346
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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 Model Number: 5820066012
• Device Catalogue Number: 5820066012
• Device Lot Number: 22280017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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