MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	0277010212
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available for return.
Event or Problem Description
It was reported that during incoming inspection at a customer site, it was noted that two burs were broken.It was also reported that this event did not occur during a surgical procedure, and there was no delay, no adverse consequences as a result of this event.This report is for the first bur that broke.
Event or Problem Description
It was reported that during incoming inspection at a customer site, it was noted that two burs were broken.It was also reported that this event did not occur during a surgical procedure, and there was no delay, no adverse consequences as a result of this event.This report is for the first bur that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.Device not returned, photograph provided.

• Brand Name: 1.2MM CROSS-CUT FISSURE CARBIDE BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 16404002
• Report Number: 3015967359-2023-00445
• Device Sequence Number: 19655658
• Product Code: GFF
• UDI-Device Identifier: 04546540050496
• UDI-Public: 04546540050496
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 06/08/2023

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 Expiration Date: 06/01/2025
• Device Model Number: 0277010212
• Device Catalogue Number: 0277010212
• Device Lot Number: 20174017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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