MAUDE Adverse Event Report: Stryker Endoscopy-San Jose OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM SINGLE; fastener, fixation, nondegradable, soft tissue

Catalog Number	3910-500-471
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the item was used post expiration in a case.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM SINGLE
• Common Device Name: fastener, fixation, nondegradable, soft tissue
• Manufacturer (Section D): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 50488534
• Report Number: 0002936485-2026-00743
• Device Sequence Number: 16097791
• Product Code: MBI
• UDI-Device Identifier: 37613327464819
• UDI-Public: 37613327464819
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-500-471
• Device Lot Number: 24143AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown