MAUDE Adverse Event Report: Stryker Endoscopy-San Jose ALPHAVENT SUTURE ANCHOR 4.75MM PEEK SUTURE ANCHOR WITH 2 STRANDS 1.8MM X; fastener, fixation, nondegradable, soft tissue

Catalog Number	3910-947-120
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: ALPHAVENT SUTURE ANCHOR 4.75MM PEEK SUTURE ANCHOR WITH 2 STRANDS 1.8MM X
• 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: 50702156
• Report Number: 0002936485-2026-00930
• Device Sequence Number: 17621242
• Product Code: MBI
• UDI-Device Identifier: 07613327563023
• UDI-Public: 07613327563023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Expiration Date: 03/14/2026
• Device Catalogue Number: 3910-947-120
• Device Lot Number: 24074AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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