MAUDE Adverse Event Report: COLTENE/WHALEDENT AG DIATECH DIAMOND INSTRUMENTS; DIAMOND DENTAL BUR

Model Number	210857DD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An issue with a dental burr that occurred in the dental clinic at (b)(6) hospital.A flame-d862-012-8.0/ml was used in a procedure, and a tip broke off and was swallowed.No reported injury but the patient was hospitalized.Patient was subsequently discharged with no other known negative impact at this time.Hospital wrote at (b)(6) 2022: "unfortunately, we are unable to provide additional information at this time.".
Additional Manufacturer Narrative
See attachment.

• Brand Name: DIATECH DIAMOND INSTRUMENTS
• Common Device Name: DIAMOND DENTAL BUR
• Manufacturer (Section D): COLTENE/WHALEDENT AG; feldwiesenstrasse 20; altstätten, ch-9450 ; SZ
• Manufacturer (Section G): COLTENE/WHALEDENT AG; feldwiesenstrasse 20; altstätten, ch-9450 ; SZ
• Manufacturer Contact: roland streuf ; feldwiesenstrasse 20; altstätten, ch-9450 ; SZ
• MDR Report Key: 15184319
• Report Number: 9613375-2022-00001
• Device Sequence Number: 14939086
• Product Code: DZP
• UDI-Device Identifier: J006210857DD0
• UDI-Public: J006210857DD0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 210857DD
• Device Catalogue Number: D862-012-8.0/ML
• Device Lot Number: L15788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown