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

Model Number 460405

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

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 Description

This is 1 of 3 reports and is linked to mfg report numbers: 3014334038-2022-00240, 3014334038-2022-00241.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.

Manufacturer Narrative

There has been no return of product after three (3) good faith efforts (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 failure were found.A definitive root cause of the reported issue 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
• Type of Device: 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: 15670797
• MDR Text Key: 306997660
• Report Number: 3014334038-2022-00239
• Device Sequence Number: 1
• Product Code: EJL
• UDI-Device Identifier: 10381780394174
• UDI-Public: 10381780394174
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1