MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY MFG CO., LLC.; H6/H7 DE SCALER, EE2 #9 HANDLE

Model Number	SH6/79E2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Breakage due to crack in instrument.The observed cutting-edge dulling and lack of timely resharpening may have contributed to increased force applied during clinical use, further promoting crack propagation and eventual fracture.No evidence of manufacturing or material defect was identified.
Event or Problem Description
Customer reported that instrument broke and the patient stated they swallowed the tip/piece.Patient received an x-ray and the instrument piece was not visible on x-ray.

• Brand Name: HU-FRIEDY MFG CO., LLC.
• Common Device Name: H6/H7 DE SCALER, EE2 #9 HANDLE
• 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: 24903876
• Report Number: 1416605-2026-00005
• Device Sequence Number: 9195766
• Product Code: EMN
• UDI-Device Identifier: 10889950028367
• UDI-Public: (01)10889950028367
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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
• Device Model Number: SH6/79E2
• Device Catalogue Number: SH6/79E2
• Device Lot Number: 0424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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