MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5.0MM COARSE DIAMOND ROUND, DISTAL BEND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8431-013-050DC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that all parts of the broken bur were retrieved successfully from the patient.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting for device return to manufacturer.
Additional Manufacturer Narrative
The quality investigation is complete.Product status unknown.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that all parts of the broken bur were retrieved successfully from the patient.It was further reported that the procedure was completed successfully.

• Brand Name: 5.0MM COARSE DIAMOND ROUND, DISTAL BEND
• 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: 16731681
• Report Number: 3015967359-2023-00726
• Device Sequence Number: 12411536
• Product Code: HBE
• UDI-Device Identifier: 07613327501186
• UDI-Public: 07613327501186
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K210377
• 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): 07/17/2023

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: 8431-013-050DC
• Device Catalogue Number: 8431013050DC
• Device Lot Number: 22224017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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