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

Catalog Number	CAT00776
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the process of entering the hip joint the stryker blunt plastic cannula was pinched between the lateral rim of the acetabulum end femoral head and approximately 1.6cm plastic piece broke off.X-rays revealed that it was pinched between the lateral acetabulum and femoral head.The final x rays revealed a well reduced hip joint with retained plastic piece unchanged from intraoperative x-rays.
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.
Additional Manufacturer Narrative
The device was not returned 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: tip breaking.Probable root cause: application, excessive force, poor visualization through arthroscope.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during the process of entering the hip joint the stryker blunt plastic cannula was pinched between the lateral rim of the acetabulum end femoral head and approximately 1.6cm plastic piece broke off.X-rays revealed that it was pinched between the lateral acetabulum and femoral head.The final x rays revealed a well reduced hip joint with retained plastic piece unchanged from intraoperative x-rays.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR
• 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 ; 4087542000
• MDR Report Key: 21277214
• Report Number: 0002936485-2025-00071
• Device Sequence Number: 3627281
• Product Code: NBH
• UDI-Device Identifier: 07613252632887
• UDI-Public: 07613252632887
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Catalogue Number: CAT00776
• Device Lot Number: UNKNOWN
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White