MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC XT TRIPLE BEND SWIVEL DIRECT FLOW; XT TRIPLE BEND INSERT

Model Number	UI30SDXTTB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the tip of their xt triple bend insert broke off into the patient's mouth.The tip of the device was unable to be located however, the procedure was completed successfully.Following the procedure, the patient was advised to receive x-rays.The tip of the device was observed in the x-rays.It is unknown if or how the tip was removed.No report of injury.
Additional Manufacturer Narrative
The xt triple bend insert subject of the reported event was returned for evaluation.Evaluation results determined that the tip breakage may be attributed to the instrument being dropped prior to the patient procedure or mishandled by user facility personnel.The reprocessing of hu-friedy dental hand instruments and accessories states (section 3.2), "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments." the device history record (dhr) for the subject lot was reviewed and no abnormalities were noted.User facility personnel will be advised of the evaluation results for the xt triple bend insert subject of the reported event.

• Brand Name: XT TRIPLE BEND SWIVEL DIRECT FLOW
• Common Device Name: XT TRIPLE BEND INSERT
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 3232 n rockwell st.; chicago, IL 60618 ; 4403927453
• MDR Report Key: 19272639
• Report Number: 1416605-2024-00003
• Device Sequence Number: 17999662
• Product Code: ELC
• UDI-Device Identifier: 10889950075675
• UDI-Public: 10889950075675
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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: UI30SDXTTB
• Device Catalogue Number: UI30SDXTTB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown