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	Foreign Body In Patient (2687)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Alleged failure: the air was opened during the operation for meniscus suture.At that time, the marker of the outer tube was confirmed, but the marker part had disappeared after the anchor was placed in the joint.The anchor could be placed without any problems, and there were no problems.This is the first time that the marker has disappeared.Then used two airs, but the same event did not happen.There was no problem with the anchor, and the procedure ended.It hasn't happened to other products that are using the same.I was continues flashing.Could you tell me if it's okay that the marker disappears in the body? the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: incision too small, user does not use sled or other technique to prevent catching on soft tissue, excessive force applied on device, or manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.No manufacturing date - the device manufacturer date is not known.
Event or Problem Description
It was reported that there was material left in the patient.

• 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: 10427340
• Report Number: 0002936485-2020-00346
• Device Sequence Number: 16572087
• Product Code: GAT
• UDI-Device Identifier: 07613327375404
• UDI-Public: 07613327375404
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4720
• Device Catalogue Number: 4720
• Device Lot Number: 7003432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other