MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIR+ MENISCAL SYSTEM - CURVED UP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	4722
Medical Device Problem Codes	Material Fragmentation (1261); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: upon the first deployment of the curved air max meniscal suture, it loads correctly, but when fired, both peek implants are released simultaneously.The surgeon has requested that this issue be reported to quality, and the item will not be charged.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Visual inspection: the anchors were deployed.Both anchors were damaged; one was broken, and the other was bent.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, 5) user not familiar with device use.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that upon the first deployment of the curved air max meniscal suture, it loads correctly, but when fired, both peek implants are released simultaneously.
Additional Manufacturer Narrative
Alleged failure: upon the first deployment of the curved air max meniscal suture, it loads correctly, but when fired, both peek implants are released simultaneously.The surgeon has requested that this issue be reported to quality, and the item will not be charged.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.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, 5) user not familiar with device use.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that upon the first deployment of the curved air max meniscal suture, it loads correctly, but when fired, both peek implants are released simultaneously.

• Brand Name: AIR+ MENISCAL SYSTEM - CURVED UP
• 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: 23337506
• Report Number: 0002936485-2025-00854
• Device Sequence Number: 7956881
• Product Code: GAT
• UDI-Device Identifier: 07613327482065
• UDI-Public: 07613327482065
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K153087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 4722
• Device Lot Number: 7015432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 10/29/2025
• 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