MAUDE Adverse Event Report: AVALIGN TEHNOLOGIES INC AVALIGN; WEIL-BLAKESLEY FORCEPS FENESTRATED, STRAIGHT, 00 2.5 X 5 MM CUP WORKI

Model Number	RH551-111
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04aug2025, avalign gsi quality received a customer complaint notification.Complaint from customer for one unit of customer part# rh551-111.It was reported that a piece of instrument broke off in the patient's nasal cavity, and the broken piece was retrieved and intact.There was no additional intervention, the patient was discharged with injury.The procedure was not delayed.

• Brand Name: AVALIGN
• Common Device Name: WEIL-BLAKESLEY FORCEPS FENESTRATED, STRAIGHT, 00 2.5 X 5 MM CUP WORKI
• Manufacturer (Section D): AVALIGN TEHNOLOGIES INC; 626 cooper ct; schaumburg IL 60173
• Manufacturer Contact: alexis kurz ; 626 cooper ct; schaumburg, IL 60173 ; 8479080292
• MDR Report Key: 22896626
• Report Number: 1421101-2025-00002
• Device Sequence Number: 8897004
• Product Code: KAE
• UDI-Device Identifier: 10885403110221
• UDI-Public: 10885403110221
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: RH551-111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/26/2025
• 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