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

Model Number	CAT01549
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/23/2019
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 device broke in the joint and the surgeon converted to open procedure to remove the tip.
Additional Manufacturer Narrative
Alleged failure: the device broke during the procedure; surgeon was unable to locate foreign object so converted to open.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the device broke in the joint and the surgeon converted to open procedure to remove the tip.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR, LINVATEC & STORZ
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9140211
• Report Number: 0002936485-2019-00436
• Device Sequence Number: 16881631
• Product Code: NBH
• UDI-Device Identifier: 07613252633051
• UDI-Public: 07613252633051
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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 Model Number: CAT01549
• Device Catalogue Number: CAT01549
• Device Lot Number: 003820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR