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	12/11/2018
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 device was cracking during the procedure.A replacement was used and the procedure was completed successfully.
Event or Problem Description
It was reported that the device was cracking during the procedure.A replacement was used and the procedure was completed successfully.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: cracked.Probable root cause: - poor autoclave reliability - use error.

• 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: 8224568
• Report Number: 0002936485-2019-00008
• Device Sequence Number: 19289559
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 18041AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1