MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARBIDE BURS - FG 700L PACK OF 10; M51 - GENERAL DENTISTRY

Model Number	460405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This is 3 of 3 reports and is linked to mfg report numbers: 3014334038-2022-00239, 3014334038-2022-00240.A facility reported having issues with the carbide burs (dfg700l) breaking, immediately.It was reported that this event occurred during dental extraction.Pieces fell into the surgical site and was removed with thumb forceps.Not all broken pieces were recovered; however, no pieces were left inside the patient.No patient injury or significant delay in surgery occurred.
Additional Manufacturer Narrative
There has been no return of the suspected carbide burs (dfg700l) after three (3) good faith effort (gfe) attempts; therefore, an evaluation of the device could not be performed.Lot number information has been provided; device history record (dhr) was reviewed, and no anomalies related to the reported complaint were found.A definitive root cause could not be determined.The issue of breaking burs may be the result of misalignment during procedure or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CARBIDE BURS - FG 700L PACK OF 10
• Common Device Name: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15670601
• Report Number: 3014334038-2022-00241
• Device Sequence Number: 17766508
• Product Code: EJL
• UDI-Device Identifier: 10381780394174
• UDI-Public: 10381780394174
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 460405
• Device Catalogue Number: DFG700L
• Device Lot Number: 1433551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown