MAUDE Adverse Event Report: MILLENNIUM SURGICAL CORP MILLENNIUM SURGICAL CORP; MENISCAL CLAMP W TEETH

Model Number	1-1883
Medical Device Problem Codes	Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint from customer plum creek surgery center for one (1) unit of item #1-1883 from lot a407.A tooth broke off during normal surgery intra-op use on (b)(6) 2026.There was no death or serious injury.There was no patient intervention.The condition of the patient was fine.There was a delay of twenty minutes with no impact to the patient.The broken tooth was retrieved.

• Brand Name: MILLENNIUM SURGICAL CORP
• Common Device Name: MENISCAL CLAMP W TEETH
• Manufacturer (Section D): MILLENNIUM SURGICAL CORP; 40 monument rd; bala cynwyd PA 19004
• Manufacturer Contact: kurz ; 626 coopert ct; schaumburg, IL 60173 ; 8479080292
• MDR Report Key: 24670144
• Report Number: 3004215117-2026-00001
• Device Sequence Number: 5055591
• Product Code: GDJ
• UDI-Device Identifier: 00190776170288
• UDI-Public: 00190776170288
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1-1883
• Device Lot Number: A407
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• 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: Unknown