MAUDE Adverse Event Report: HU-FRIEDY MANUFACTURING CO., LLC #23/UNC12 EXPRO #7 HANDLE; EXPRO PROBE

Model Number	XP23/NC127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a dental procedure the tip of the probe broke in patient's mouth and the patient might have swallowed it.A radiograph was taken to locate the tip and they found no evidence of the tip.Patient declined any further medical intervention.
Additional Manufacturer Narrative
The device subject of the reported event was returned to hu-friedy for evaluation.The probe tip was likely subjected to excessive force during use, leading to the breakage of the point.This indicates a use-related failure mechanism.The device history record for the subject lot was reviewed.Return rates and complaint rates are low, no further action will be taken.

• Brand Name: #23/UNC12 EXPRO #7 HANDLE
• Common Device Name: EXPRO PROBE
• Manufacturer (Section D): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n. rockwell st; chicago, IL 60618 ; 8472574500
• MDR Report Key: 24702145
• Report Number: 1416605-2026-00004
• Device Sequence Number: 16069282
• Product Code: EIX
• UDI-Device Identifier: 10889950034931
• UDI-Public: (01)10889950034931
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: Other
• Device Model Number: XP23/NC127
• Device Catalogue Number: XP23/NC127
• Device Lot Number: 0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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