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	Insufficient Information (4580)
Date of Event	07/29/2024
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 surgeon introduced the flowport cannula through his incision and into the joint space.As the samuari blade was introduce into the cannula, it was retracted back in order to cut the capsule and the surgeon noticed the distal leading plastic edge of the cannula had broken off the metal portion of the cannula.The arthroscopy was cancelled and the surgeon had to perform an arthrotomy to retrieve the broken plastic piece.The posted procedure had to be stopped and has to be conducted at a later time due to the arthrotomy of the joint capsule.The procedure turned from an arthroscopy to open joint arthrotomy to successfully retrieve the broken piece.
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 broke at the proximal end.Probable root cause: application: excessive force.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the surgeon introduced the flowport cannula through his incision and into the joint space.As the samuari blade was introduce into the cannula, it was retracted back in order to cut the capsule and the surgeon noticed the distal leading plastic edge of the cannula had broken off the metal portion of the cannula.The arthroscopy was cancelled and the surgeon had to perform an arthrotomy to retrieve the broken plastic piece.The posted procedure had to be stopped and has to be conducted at a later time due to the arthrotomy of the joint capsule.The procedure turned from an arthroscopy to open joint arthrotomy to successfully retrieve the broken piece.

• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20101297
• Report Number: 0002936485-2024-00628
• Device Sequence Number: 8442424
• Product Code: NBH
• UDI-Device Identifier: 07613252633181
• UDI-Public: 07613252633181
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/22/2024

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: CAT02438
• Device Lot Number: 010903
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown