MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY; #11/12 ODU DE EXPLORER, #7 HANDLE

Model Number	EXD11/127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Instructor (b)(6) called in and reported during treatment, a faculty member was using an 11/12 explorer and the entire working end dislodged from the handle during exploring in the patients mouth.Patient swallowed the working end.Patient was instructed to go to the local emergency room at the hospital.
Additional Manufacturer Narrative
Based on the available evidence, the dislodgement of the working end is most likely attributable to excessive external mechanical forces applied during use, rather than an inherent material, design, or manufacturing defect.No related defects identified in inspection history for this lot low complaint and return rates.

• Brand Name: HU-FRIEDY
• Common Device Name: #11/12 ODU DE EXPLORER, #7 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: 24834694
• Report Number: 1416605-2026-00003
• Device Sequence Number: 9187326
• Product Code: EKB
• UDI-Device Identifier: 10889950010829
• UDI-Public: (01)10889950010829
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: EXD11/127
• Device Catalogue Number: EXD11/127
• Device Lot Number: 0624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown