MAUDE Adverse Event Report: Stryker Endoscopy-San Jose FLOWPORT II CANNULA WITH OBTURATOR STRYKER; accessories, arthroscopic

Catalog Number	CAT01548
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
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 the flowport broke cleanly in the middle of the cannula during insertion, and we spent approximately 25 minutes attempting to retrieve the broken piece from the patient.After these failures, the surgeon made the decision to abandon the labral repair and instead debride and remove the patient¿s labrum.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR STRYKER
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25566582
• Report Number: 0002936485-2026-00397
• Device Sequence Number: 18640714
• Product Code: NBH
• UDI-Device Identifier: 07613252633037
• UDI-Public: (01)07613252633037(17)271203(10)011527
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CAT01548
• Device Lot Number: 011527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Supplement Date Received by Manufacturer: 08/21/2026; 08/21/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/23/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown