MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM OVAL SOLID CARBIDE BUR LONG; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5300020901
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, at the start of rotation of the bur, the bur broke cleanly into three pieces.It was also reported that a second bur was used and it also broke into two pieces, resulting in a delay of forty five minutes.The procedure was completed successfully using a backup device; no adverse consequences or medical intervention were reported.This report is for the first bur that broke.
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 a surgical procedure, at the start of rotation of the bur, the bur broke cleanly into three pieces.It was also reported that a second bur was used and it also broke into two pieces, resulting in a delay of forty five minutes.The procedure was completed successfully using a backup device; no adverse consequences or medical intervention were reported.This report is for the first bur that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 4.0MM OVAL SOLID CARBIDE BUR LONG
• 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: 16113936
• Report Number: 3015967359-2023-00017
• Device Sequence Number: 5668035
• Product Code: GFF
• UDI-Device Identifier: 07613153001126
• UDI-Public: 07613153001126
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 5300020901
• Device Catalogue Number: 5300020901
• Device Lot Number: 22136017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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