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

Model Number	CAT00776
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during the procedure.The piece was retrieved.
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
Alleged failure: (b)(6) suggested i email you regarding a defective flowport cannula (ref cat00776 lot 006754).The case took place (b)(6) 2022 at (b)(6) in (b)(6).The distal tip of the cannula snapped off intraoperatively as dr (b)(6) was twisting it into the patient.It was atraumatic.To retrieve it dr.(b)(6) had to advance the broken piece into the patients joint and retrieve it with a grasper.This added about 30 mins to the case.The case was completed successfully.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.Manufacture date is not known.
Event or Problem Description
It was reported that the device broke during the procedure.The piece was retrieved.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13549292
• Report Number: 0002936485-2022-00093
• Device Sequence Number: 4865038
• Product Code: NBH
• UDI-Device Identifier: 07613252632887
• UDI-Public: 07613252632887
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/24/2022

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 Model Number: CAT00776
• Device Catalogue Number: CAT00776
• Device Lot Number: 006754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/24/2022
• 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