MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, OBTURATOR 6.5; ACCESSORIES, ARTHROSCOPIC

Catalog Number 0377031610

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2020

Event Type  Injury  

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 Description

It was reported that the tip of the arthroscopic cannula broke during procedure & pieces potentially remained in joint.Please note that the procedure was completed successfully.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: torn arthroscopic cannula probable root cause: poor autoclave reliability use error the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that the tip of the arthroscopic cannula broke during procedure & pieces potentially remained in joint.Please note that the procedure was completed successfully.

• Brand Name: PKG, OBTURATOR 6.5
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9733598
• MDR Text Key: 180616683
• Report Number: 0002936485-2020-00066
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327057737
• UDI-Public: 07613327057737
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0377031610
• Device Lot Number: 15E0033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other