MAUDE Adverse Event Report: RESTOR3D, INC ITOTAL KNEE INSTRUMENTS; ITOTAL REUSABLE INSTRUMENTS

Model Number	1080-213
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Tine from impactor adaptor broke off during surgery and was inadvertently left in the patient.The hospital noticed metal included in patient's knee post-opertion x-ray and sheduled an exploratory revision surgery, during which they located and removed the metal tine.
Additional Manufacturer Narrative
Tine from impactor adapter broke off during surgery and was inadvertently left in the patient.Patient is otherwise doing well.Investigation of the failure is ongoing.

• Brand Name: ITOTAL KNEE INSTRUMENTS
• Common Device Name: ITOTAL REUSABLE INSTRUMENTS
• Manufacturer (Section D): RESTOR3D, INC; 600 research dr; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27705
• MDR Report Key: 23657858
• Report Number: 3004153240-2025-00021
• Device Sequence Number: 4824185
• Product Code: JWH
• UDI-Device Identifier: 00810933030599
• UDI-Public: (01)00810933030599
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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
• Device Model Number: 1080-213
• Device Lot Number: M190401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown