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.
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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.
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