MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number	CAT02438
Medical Device Problem Codes	Fracture (1260); Product Quality Problem (1506); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 foreign material inside the sterile package.
Additional Manufacturer Narrative
Sale representative confirmed product will not be coming in-house for evaluation.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: foreign material inside the sterile package probable root cause: process - uncontrolled environmental conditions the reported failure mode will be monitored for future reoccurrence the device manufacture date is not known.
Event or Problem Description
It was reported that there was foreign material inside the sterile package.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: eric san miguel ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21712769
• Report Number: 0002936485-2025-00253
• Device Sequence Number: 10130749
• Product Code: NBH
• UDI-Device Identifier: 07613252633181
• UDI-Public: 07613252633181
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/05/2025

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: CAT02438
• Device Lot Number: 010524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/05/2025
• 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