MAUDE Adverse Event Report: DePuy Ireland - 9616671 ACTIS; Insertion Devices

Catalog Number	201007100
Medical Device Problem Code	Break (1069)
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: Insertion Devices
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50722947
• Report Number: 1818910-2026-15552
• Device Sequence Number: 13325824
• Product Code: LXH
• UDI-Device Identifier: 10603295393986
• UDI-Public: (01)10603295393986(10)AB4660410
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 201007100
• Device Lot Number: AB4660410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2021
• 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