MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	02.12.10.1961
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Metal fragment noticed on postop xrays encapsulated in bone cement in tibia canal.While looking through surgical instruments, found metal sheared off tibia reaming guide.

• Brand Name: KNEE INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; 6386 global drive, suite 101; memphis TN 38141
• MDR Report Key: 22518816
• Report Number: 22518816
• Device Sequence Number: 8633226
• Product Code: LXH
• UDI-Device Identifier: 07630345785824
• UDI-Public: (01)07630345785824(10)2356980
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 02.12.10.1961
• Device Lot Number: 2356980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Date Report Sent to FDA: 07/11/2025