MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.2MM TAPER SIDE CUTTING CARBIDE BUR; BUR, DENTAL

Model Number	1607002105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during a dental procedure, the bur broke.It was also reported the piece of broken bur was retrieved from the patient and that there were no adverse consequences as a result of this event.It was further reported that there was a slight unspecified delay and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was reported that during a dental procedure, the bur broke.It was also reported the piece of broken bur was retrieved from the patient and that there were no adverse consequences as a result of this event.It was further reported that there was a slight unspecified delay and the procedure was completed successfully.

• Brand Name: 1.2MM TAPER SIDE CUTTING CARBIDE BUR
• Common Device Name: BUR, DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11695143
• Report Number: 3015967359-2021-00469
• Device Sequence Number: 11796868
• Product Code: EJL
• UDI-Device Identifier: 04546540030337
• UDI-Public: 04546540030337
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 05/06/2021

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: 05/01/2023
• Device Model Number: 1607002105
• Device Catalogue Number: 1607002105
• Device Lot Number: 18131017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1