MAUDE Adverse Event Report: DePuy Ireland - 3015516266 ACTIS; Instrument Cases

Catalog Number	201004200
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction

• Brand Name: ACTIS
• Common Device Name: Instrument Cases
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50674595
• Report Number: 1818910-2026-15294
• Device Sequence Number: 14785304
• Product Code: FSM
• UDI-Device Identifier: 10603295393887
• UDI-Public: (01)10603295393887
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup

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 Catalogue Number: 201004200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown