MAUDE Adverse Event Report: DEPUY SYNTHES, INC. DEPUY SYNTHES RIA MEDULLARY REAMER HEAD 12.5 MM REAMER HEAD FOR RIA 2

Model Number	352.125 FOR 12.5MM REAMER HEAD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Depuy reamer head broke off while doctor was sizing.

• Brand Name: DEPUY SYNTHES RIA MEDULLARY REAMER HEAD 12.5 MM REAMER HEAD FOR RIA 2
• Common Device Name: REAMER
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 23109646
• Report Number: MW5176287
• Device Sequence Number: 9833080
• Product Code: HTO
• UDI-Device Identifier: 10886982273963
• UDI-Public: 10886982273963
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: 352.125 FOR 12.5MM REAMER HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White