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

Model Number	4720
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was unintended material in the joint.The surgeon was able to sue the shaver to remove the flakes without issue.
Event or Problem Description
It was reported that there was unintended material in the joint.The surgeon was able to sue the shaver to remove the flakes without issue.
Additional Manufacturer Narrative
Alleged failure: during a meniscal repair - surgeon was using stryker air.When deploying the anchors it was noticed on the screen during the arthroscopic case that the black measurement lines, on the white cannula of the air, were falling off the cannula and floating in the joint space.Surgeon was able to use the shaver to suck out the flakes without issue.Noticed during knee arthroscopy case, on screen inside the joint capsule.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) incision too small, 2) user does not use sled or other technique to prevent catching on soft tissue, 3) excessive force applied on device, or 4) manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: AIR MENISCUS SYSTEM, CURVED
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10271574
• Report Number: 0002936485-2020-00270
• Device Sequence Number: 11529308
• Product Code: GAT
• UDI-Device Identifier: 07613327375404
• UDI-Public: 07613327375404
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153087
• 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): 09/01/2020

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 Model Number: 4720
• Device Catalogue Number: 4720
• Device Lot Number: 7002471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1