MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC GT FIBER POST 1MM; POST, ROOT CANAL

Catalog Number GTPOSTF1

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Investigation results: returned 1x gtpostf1 drill.  checked under microscope and found no manufacturing marks or defects.  see attached photo, break occurred between the handle and the 1st calibration line.  unit setting and number of uses is unknown.  no other complaints for this lot number.  no unopened product was returned therefore no further testing can be performed and root cause is unknown.Dhr: nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.

Event Description

In this event it is reported that gt fiber post 1mm - post drill broke during use.The broken pieces were retrieved and no injury resulted.

• Brand Name: GT FIBER POST 1MM
• Type of Device: POST, ROOT CANAL
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19091500
• MDR Text Key: 340572257
• Report Number: 2320721-2024-00021
• Device Sequence Number: 1
• Product Code: ELR
• UDI-Device Identifier: D716GTPOSTF11
• UDI-Public: D716GTPOSTF11
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: GTPOSTF1
• Device Lot Number: 0000392513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/02/2024
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1