MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV; ACCESSORIES,ARTHROSCOPIC

Model Number	72200829
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were black debris in the joint.It was thinking that there is shredding of the ring.All of the material was flushed out of the patient.The procedure was completed with a backup device with no delay or patient injury reported.
Additional Manufacturer Narrative
One 6mm high-flow double valve rotatable cannula was returned for evaluation.Visual assessment of the device showed no surface damage.Removal of the o'ring showed no material missing or deterioration of any kind.Examination of the devices cannulations using an arthroscope showed what appears to be human matter within the cannula body and stopcocks.The cannula was inspected per the inspection procedure and found to meet print specification.This investigation could not identify any evidence of product contribution to the reported complaint.
Additional Manufacturer Narrative
For the initial mdr in thetab, read correctly (b)(4) 2018 instead of (b)(4) 2018.

• Brand Name: CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7715633
• Report Number: 1219602-2018-00927
• Device Sequence Number: 1065294
• Product Code: NBH
• UDI-Device Identifier: 03596010573520
• UDI-Public: (01)03596010573520(10)50713836
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2018

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 Model Number: 72200829
• Device Catalogue Number: 72200829
• Device Lot Number: 50713836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 08/27/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/08/2018; 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1