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); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was physically received at stryker endoscopy, usa.Alleged failure: after the first needle was inserted into the meniscus, the first peek anchor was released according to the manufacturer's recommendation.When the needle was pulled out, the anchor followed the needle and the system was not capable of further use.Visual inspection: the anchors were deployed.The anchor was broken.The piece was not returned.The suture was broken as well.The inserter and depth indicator were visually inspected for discrepancies and observed none.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) incision too small, 3) inadequate or improper visualization, 4) user does not use sled or other technique to prevent catching on soft tissue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that after the first needle was inserted into the meniscus, the first peek anchor was released.When the needle was pulled out, the anchor followed the needle and the system was not capable of further use.

• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23351119
• Report Number: 0002936485-2025-00858
• Device Sequence Number: 15651289
• Product Code: GAT
• UDI-Device Identifier: 07613327482072
• UDI-Public: 07613327482072
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 10/21/2025

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: 4723
• Device Lot Number: 7015217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/21/2025
• 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