MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; FORCEPS, TOOTH EXTRACTOR, SURGICAL

Model Number	F151XAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was returned to manufacturer.Measurement of a sampling of the serration depths showed 0.009, 0.011 and 0.010 inch depths on the returned samples.There is no iso specific requirements for serration depth.As such, the depths of the serrations were not deemed deep and within expected results.Since these are the only returns for this product code for the past 12 months, no further actions were deemed necessary.
Event or Problem Description
The customer advised that the serrations are too deep and are causing teeth to crack.

• Brand Name: HU-FRIEDY
• Common Device Name: FORCEPS, TOOTH EXTRACTOR, SURGICAL
• 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: 25056582
• Report Number: 1416605-2026-00009
• Device Sequence Number: 18677020
• Product Code: EMG
• UDI-Device Identifier: 10889950011802
• UDI-Public: (01)10889950011802
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: F151XAS
• Device Catalogue Number: F151XAS
• Device Lot Number: 1023, 0124, 0424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/01/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown