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

Model Number	0-47130
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a mako assisted left total hip case, the lewin clamp broke.The surgeon inspected the instrument and the patient; the scrub tech and circulator inspected the equipment.Spd was contacted to come and inspect the instrument; all parties involve agree that all parts of the instrument were obtained and accounted for.

• Brand Name: MILLENNIUM SURGICAL
• Common Device Name: LEWIN BONE FORCEPS
• Manufacturer (Section D): AVALIGN TECHNOLOGIES INC.; 626 cooper ct; schaumburg IL 60173
• Manufacturer Contact: alexis kurz ; 626 cooper ct; schaumburg 60173 ; 8479080292
• MDR Report Key: 24571787
• Report Number: 1421101-2026-00002
• Device Sequence Number: 18496072
• Product Code: GEN
• UDI-Device Identifier: 00190776341381
• UDI-Public: 00190776341381
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 0-47130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• 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: Male
• Patient Race: White