MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 1000 TRIPLE BEND SWIVEL DIRECT FLOW ULTRASONIC INSERT; SCALER, ULTRASONIC, PRODUCT CODE: ELC

Model Number	UI30SD1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 1000 triple bend swivel 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.No additional issues noted.
Event or Problem Description
The user facility reported that the tip of their 1000 triple bend swivel direct flow ultrasonic insert was damaged during a dental procedure and the tip was unable to be located.No injury.The patient was sent to receive a chest x-ray.No significant findings of chest x-ray.

• Brand Name: 1000 TRIPLE BEND SWIVEL DIRECT FLOW ULTRASONIC INSERT
• Common Device Name: SCALER, ULTRASONIC, PRODUCT CODE: ELC
• 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: stephanie wasielewski ; 1666 e. touhy ave.; des plaines, IL 60018 ; 8472574500
• MDR Report Key: 19625137
• Report Number: 1416605-2024-00006
• Device Sequence Number: 8121784
• Product Code: ELC
• UDI-Device Identifier: 10889950075637
• UDI-Public: 10889950075637
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: UI30SD1000
• Device Catalogue Number: UI30SD1000
• Device Lot Number: 523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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