MAUDE Adverse Event Report: Medacta International SA Knee Instruments; Pin Ø3.2 L=150 ISO5835-L=25-Meche-Triangle

Model Number	02.07.10.2303
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a nextar surgery, the 3.2 x 150 mm meche-triangle pin broke while the surgeon was repositioning it.The broken fragment could not be retrieved and was therefore left in situ.A back-up pin was subsequently used to complete the procedure.
Additional Manufacturer Narrative
Investigation performed by r&d project manager in the absence of images and based solely on the description of the event, it is not possible to determine with certainty the causes that led to the pin failure.As these pins are used in nextar procedures, the instrumentation is equipped with specific guides to assist the surgeon during pin insertion.In particular, these guides are designed to ensure the correct trajectory of the pins, thereby reducing the risk of deviation in the event of insertion that is tangential to the cortical bone.Such deviation may subject the pin to bending forces, potentially resulting in breakage at the transition between the smooth and threaded portions of the pin.Root cause:as no lot number information or affected device could be provided, a detailed investigation could not be completed.While no definitive root cause can be established, the issue reported may have resulted from application-specific factors, such as excessive bending forces, possibly in combination with the unique patient-specific conditions associated with this case; however, this cannot be confirmed based on the available information.

• Brand Name: Knee Instruments
• Common Device Name: Pin Ø3.2 L=150 ISO5835-L=25-Meche-Triangle
• Manufacturer (Section D): Medacta International SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 50732102
• Report Number: 3005180920-2026-00904
• Device Sequence Number: 13409551
• Product Code: LXH
• UDI-Device Identifier: 07630040763240
• UDI-Public: 07630040763240
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: 02.07.10.2303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male