MAUDE Adverse Event Report: Stryker Endoscopy-San Jose AIR+ MENISCAL SYSTEM - CURVED DOWN; suture, nonabsorbable, synthetic, polyethylene

Catalog Number	4723
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the needle was first inserted into the meniscus, the first peek anchor was released.When the needle was withdrawn, the anchor followed the needle and the system was no longer usable.The anchor popped out of the meniscus without anchoring properly.The next product worked correctly.
Additional Manufacturer Narrative
The investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: after the needle was first inserted into the meniscus, as recommended by the manufacturer, the first peek anchor was released.When the needle was withdrawn, the anchor followed the needle and the system was no longer usable.The anchor popped out of the meniscus without anchoring properly.The next product worked correctly.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: AIR+ MENISCAL SYSTEM - CURVED DOWN
• Common Device Name: suture, nonabsorbable, synthetic, polyethylene
• 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: 50506044
• Report Number: 0002936485-2026-00759
• Device Sequence Number: 9405283
• Product Code: GAT
• UDI-Device Identifier: 07613327482072
• UDI-Public: (01)07613327482072(17)271228(10)7015942
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 4723
• Device Lot Number: 7015942
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/20/2026; 08/20/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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