MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. WEDGE HS SUTURE ANCHOR II 5.0MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-100-035
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the item was implanted after it was expired.

• Brand Name: PKG. WEDGE HS SUTURE ANCHOR II 5.0MM
• 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 ; 4087542000
• MDR Report Key: 24533797
• Report Number: 0002936485-2026-00146
• Device Sequence Number: 13029484
• Product Code: MBI
• UDI-Device Identifier: 37613154015307
• UDI-Public: 37613154015307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 3910-100-035
• Device Lot Number: 24038AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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