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

Catalog Number	4723
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the air+ staple was damaged at the final stage while tightening the knot connecting the peek implants.One of the implants bent which caused the implants to fall back inside the joint.Based on investigation findings, the anchor was broken.Per additional information received, all pieces were removed.
Additional Manufacturer Narrative
The product has been physically received at stryker endoscopy, usa.Investigation as follows is now based on product received.Alleged failure: the air+ staple was damaged at the final stage while tightening the knot connecting the peek implants.One of the implants bent which caused the implants to fall back inside the joint.Visual inspection: the anchors were deployed.Both anchors were damaged; one was broken, and the other was bent.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 ; 4087542000
• MDR Report Key: 24395549
• Report Number: 0002936485-2026-00113
• Device Sequence Number: 13226970
• 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): 02/19/2026

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: 7015216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/19/2026
• 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