MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; SCALER, ULTRASONIC

Model Number	UI30SSXT
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Actual device was returned and tested.There was no material heat treatment issue found (51.0 hrc, 48-52 hrc specification).The back bend was found to be within specification (17.27 deg, 18 +/- 3 deg specification using key-001, keyence vision system.) there is no material heat treatment nor manufacturing issue found.The breakage may be due to dropped, bent or misused insert.Since the return rate is low, no further actions were deemed necessary.
Event or Problem Description
Device broke in patient's mouth.A flap in the gums was made to get the piece out.

• Brand Name: HU-FRIEDY
• Common Device Name: SCALER, ULTRASONIC
• 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 ; 3232 n rockwell st; chicago, IL 60618 ; 8472574500
• MDR Report Key: 25280165
• Report Number: 1416605-2026-00010
• Device Sequence Number: 18586218
• Product Code: ELC
• UDI-Device Identifier: 10889950075798
• UDI-Public: (01)10889950075798
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: UI30SSXT
• Device Catalogue Number: UI30SSXT
• Device Lot Number: 1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown