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

Catalog Number	4722
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
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 a breach in the sterile barrier.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: device delivered un-sterile.Probable root cause: dsm cm for air+ devices provided their report stating.Based on the feedback and images provided, we were able to confirm the complaint allegation of incomplete pouch seal.A dhr review was completed and reported in the preceding email on 10 apr 2024.No discrepancies applicable to this complaint were noted.The images provided show no evidence that this product pouch was sealed.This process has a 100 percent inspection for product pouch seal, which means this product pouch was erroneously passed.This is the first instance of this type of error for this product.We believe the cause of this event is an unintentional line clearance error during production.As a result of this event, all operators have undergone additional training for this product with a specific emphasis on ensuring a complete seal is present on all product pouches.No further action will be taken at this time.However, we will continue to monitor incoming complaints for trending purposes.Application: poor handling during shipping.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was a breach in the sterile barrier.

• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18897782
• Report Number: 0002936485-2024-00220
• Device Sequence Number: 7477326
• Product Code: GAT
• UDI-Device Identifier: 07613327482065
• UDI-Public: 07613327482065
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: Other
• Device Catalogue Number: 4722
• Device Lot Number: 7012969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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