MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 8.0MM X 75MM, THREADED; ACCESSORIES, ARTHROSCOPIC

Catalog Number	3910075800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the cannula cracked during case.The procedure was completed successfully.
Event or Problem Description
Please note that the initial report's type of reportable event was malfunction.Per investigation results, the device was not cracked, the tip of the cannula had a deformation.The tip having a deformation may cause user inconvenience but is not likely to result in any safety concerns.The procedure was completed successfully with no reports of medical intervention or adverse consequences.This should not result in any adverse consequences if it were to recur.Therefore making this event not reportable.
Additional Manufacturer Narrative
Alleged failure: the customer reported that two dri-lok threaded cannula cracked during the case.The case was completed using an alternative.There was a slight delay while the alternative was found.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) excessive force applied on device, 2) patient anatomy, 3) portal location, or 4) incorrect cannula diameter/length.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: 8.0MM X 75MM, THREADED
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8571414
• Report Number: 0002936485-2019-00171
• Device Sequence Number: 18905007
• Product Code: NBH
• UDI-Device Identifier: 37613327055727
• UDI-Public: 37613327055727
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 11/08/2019

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: 3910075800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1