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

Catalog Number	CAT02438
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip broke during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.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 the tip broke during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
The product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: the flowport ii cannula (cat 02438, lot: 011393) broke off in the capsule.Part of it fell into the acetabulum and had to be retrieved.Time loss approx.60 min.The second cannula from the same kit also broke after the extension was completed.The cannula was in the joint with the optics and was slightly crushed.The broken part also had to be retrieved, which took another 70 minutes.All parts could be removed.The extension time was extended by over 2 hours, the consequences for the patient are unclear.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the tip broke during the procedure.The piece was retrieved.

• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21531878
• Report Number: 0002936485-2025-00174
• Device Sequence Number: 20596806
• Product Code: NBH
• UDI-Device Identifier: 07613252633181
• UDI-Public: 07613252633181
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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: 011393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 06/05/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/22/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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