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	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting for device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the bur was vibrating.It was also reported that the event caused a short delay and no adverse consequences or medical intervention were reported.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the bur was vibrating.It was also reported that the event caused a short delay and no adverse consequences or medical intervention were reported.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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16635473
• Report Number: 3015967359-2023-00640
• Device Sequence Number: 14984214
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 02/09/2024
• 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
• Patient Sex: Unknown