MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY MFG CO., LLC.; #7/8 AFTER FIVE GRACEY CURETTE SS

Model Number	SRPG7/86
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The failure is most likely associated with crack development and propagation due to mechanical fatigue and/or stress accumulated during use.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 indication of manufacturing defect was identified.
Event or Problem Description
Dealer reported that customer stated the instrument broke off within the patients mouth.The broken part could not be removed and patient needed an x-ray at the oral surgeon.The broken piece was visible on the x-ray.

• Brand Name: HU-FRIEDY MFG CO., LLC.
• Common Device Name: #7/8 AFTER FIVE GRACEY CURETTE SS
• 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: katy peterson ; 3232 n. rockwell st; chicago, IL 60618 ; 8472574500
• MDR Report Key: 25734662
• Report Number: 1416605-2026-00014
• Device Sequence Number: 10484386
• Product Code: EMS
• UDI-Device Identifier: 10889950032456
• UDI-Public: (01)10889950032456
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: SRPG7/86
• Device Catalogue Number: SRPG7/86
• Device Lot Number: 1023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown