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 product cracked.The procedure was completed successfully.
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.
Event or Problem Description
It was reported that the product cracked.The procedure was completed successfully.

• 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: 8566744
• Report Number: 0002936485-2019-00168
• Device Sequence Number: 2192142
• 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): 07/11/2019

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
• Device Lot Number: 18232AG2
• 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: 04/30/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1