MAUDE Adverse Event Report: Depuy Spine Inc CONDUIT; Orthopedic manual surgical instrument

Catalog Number	PFT10800T
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction

• Brand Name: CONDUIT
• Common Device Name: Orthopedic manual surgical instrument
• Manufacturer (Section D): Depuy Spine Inc; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): Micropulse Inc; 5865 e, in-14; columbia city IN
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50007774
• Report Number: 1526439-2026-01084
• Device Sequence Number: 5791620
• Product Code: LXH
• UDI-Device Identifier: 10705034557458
• UDI-Public: (01)10705034557458(10)MI147791
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup,Followup,Followup,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: PFT10800T
• Device Lot Number: MI147791
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 07/24/2026; 07/28/2026; 08/24/2026; 09/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/27/2026; 07/28/2026; 08/27/2026; 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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