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

Model Number	5120066012
Medical Device Problem Codes	Fracture (1260); Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Laceration(s) (1946); Unspecified Tissue Injury (4559)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure, two burs broke requiring metal fragments to be located.It was also reported that the event contributed to a 120 minute delay.It was further reported that the event caused an unknown injury detail to the patients lip with no medical intervention reported.It was also reported that the procedure was completed successfully.This report addresses one of the bur breaks which was reported in this event.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3: awaiting for device return to manufacturer.
Additional Manufacturer Narrative
B5; it was further reported that the event caused a burn to the patients lip and a deep abrasion of the lower lip which required suturing.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, two burs broke requiring metal fragments to be located.It was also reported that the event contributed to a 120 minute delay.It was further reported that the event caused a burn to the patients lip and a deep abrasion of the lower lip which required suturing.It was also reported that the procedure was completed successfully.This report addresses one of the bur breaks which was reported in this event.

• 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: 16983011
• Report Number: 3015967359-2023-01165
• Device Sequence Number: 20546196
• Product Code: HBE
• UDI-Device Identifier: 04546540078612
• UDI-Public: 04546540078612
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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 Model Number: 5120066012
• Device Catalogue Number: 5120066012
• Device Lot Number: 21306017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown