MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES INC AVALIGN; LEWIN BONE FORCEPS

Model Number	VM38-1931
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 30jun2025, quality received a customer complaint notification.The customer stated: "we are having some issues with this specific instrument.We have broken probably 4 of them so far, when put under even slight pressure.One of the ends completely snapped off during a surgery today while trying to grab hold of the femoral neck as you can see in the picture i've attached.No patient injuries were had.".

• Brand Name: AVALIGN
• Common Device Name: LEWIN BONE FORCEPS
• Manufacturer (Section D): AVALIGN TECHNOLOGIES INC; 626 cooper ct; schaumburg IL 60183
• Manufacturer Contact: alexis kurz ; 626 cooper ct; schaumberg, IL 60173 ; 8479080292
• MDR Report Key: 22616666
• Report Number: 1421101-2025-00001
• Device Sequence Number: 9737745
• Product Code: GEN
• UDI-Device Identifier: 00190776060923
• UDI-Public: 00190776060923
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/22/2025

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: VM38-1931
• Device Lot Number: 050124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/25/2025
• 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