MAUDE Adverse Event Report: HU-FRIEDY MANUFACTURING CO., LLC 150AS(X) SPLIT BEAK PEDO FORCEPS, SERR

Model Number	F150XAS
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
Event or Problem Description
The customer advised that the serrations are too deep and they are causing teeth to crack.
Additional Manufacturer Narrative
Measurement of a sampling of the serration depths showed 0.009, 0.011, 0.010 inch depths on the returned samples.The depths of the serrations were not deemed deep.The applied force to teeth may be excessive.No return rates for these intruments, no further actions will be taken.

• Brand Name: 150AS(X) SPLIT BEAK PEDO FORCEPS, SERR
• Common Device Name: PEDO FORCEPS
• 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: 25043885
• Report Number: 1416605-2026-00008
• Device Sequence Number: 13241924
• Product Code: EMG
• UDI-Device Identifier: 10889950011734
• UDI-Public: (01)10889950011734
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: F150XAS
• Device Catalogue Number: F150XAS
• Device Lot Number: 0125, 0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• 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: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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