MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.6MM TAPER SIDE CUTTING CARBIDE BUR; BUR, DENTAL

Model Number	1607002107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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 surgical procedure, the bur broke.No additional information was provided.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.No additional information was provided.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 1.6MM 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: 11789884
• Report Number: 3015967359-2021-00805
• Device Sequence Number: 17128433
• Product Code: EJL
• UDI-Device Identifier: 04546540466495
• UDI-Public: 04546540466495
• 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): 06/10/2021

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: 07/01/2025
• Device Model Number: 1607002107
• Device Catalogue Number: 1607002107
• Device Lot Number: 20209017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1