MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HENRY SCHEIN MAXIMA DISTAL END CUTTER; ORTHODONTIC PLIER

Model Number	900-7599
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to manufacturer.Device history file review could not be completed as no lot number was provided for the device.With no device in hand, root cause analysis of the issue is limited.Complaint and return history were reviewed for the device.
Event or Problem Description
A piece of the working end of the device broke inside the patient's mouth during an ortho procedure.They were sent to er and imaging found the piece in their intestine.Patient was scheduled for follow up in two weeks to have it removed.The piece was later discharged from the body and no surgical intervention was required.

• Brand Name: HENRY SCHEIN MAXIMA DISTAL END CUTTER
• Common Device Name: ORTHODONTIC PLIER
• 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: 24911651
• Report Number: 1416605-2026-00006
• Device Sequence Number: 21289085
• Product Code: JEX
• UDI-Device Identifier: 00304040120293
• UDI-Public: (01)00304040120293
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 900-7599
• Device Catalogue Number: 900-7599
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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