MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.; OSTEOTOME

Model Number	2421-03-000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Osteotome - had broken during surgery and was located within the surgical field, with all fragments accounted for.

• Brand Name: NA
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 24198728
• Report Number: 24198728
• Device Sequence Number: 17526410
• Product Code: HWM
• UDI-Device Identifier: 10603295122739
• UDI-Public: (01)10603295122739
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/15/2026
• Report Date (Section F): 01/15/2026

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
• Device Model Number: 2421-03-000
• Device Catalogue Number: 242103000
• Device Lot Number: (10) S02043834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Date Report Sent to FDA: 01/15/2026