MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ALPHAVENT SUTURE ANCHOR 4.75MM PEEK SUTURE ANCHOR WITH 2 STRANDS 1.8MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-947-020
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an expired product was used.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
According to what was reported, the device is not available for evaluation as it remained in the patient.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: expired product implanted probable root cause: application use past device/packaging shelf life user contaminates device rough handling of sterile packaging use of expired product user not familiar with pouch seal concept user not familiar with foil pouch concept failure to verify expiration status of product prior to surgery user handling inappropriate for aseptic transfer/user not trained to perform aseptic transfer user handling error when removing from pouch other source of contamination introduced to patient during proc the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that an expired product was used.

• Brand Name: ALPHAVENT SUTURE ANCHOR 4.75MM PEEK SUTURE ANCHOR WITH 2 STRANDS 1.8MM XBRAID TT
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20412037
• Report Number: 0002936485-2024-00689
• Device Sequence Number: 9070680
• Product Code: MBI
• UDI-Device Identifier: 07613327562910
• UDI-Public: 07613327562910
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 3910-947-020
• Device Lot Number: 2206AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2022
• 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