MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OBTURATOR,INTEL 4MM A'SP FOR; ACCESSORIES,ARTHROSCOPIC

Model Number	4356
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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.Doctors thinks there is shredding of the ring.All of the material was flushed out of the patient.No patient injury reported.
Additional Manufacturer Narrative
One 4mm obturator was returned for evaluation.Visual assessment of the device showed no defects that would contribute to the reported complaint.The device was tested with a 6mm high flow double valve cannula and was found to function as intended.This investigation could not identify any evidence of product contribution to the reported complaint.Has been corrected for the initial mdr, the date of the inital mdr should be read as (b)(4) 2018 instead of (b)(4) 2018.
Event or Problem Description
It was reported that there were black debris in the joint.Doctors thinks there is shredding of the ring.All of the material was flushed out of the patient.No patient injury reported.

• Brand Name: OBTURATOR,INTEL 4MM A'SP FOR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7726236
• Report Number: 1219602-2018-00938
• Device Sequence Number: 19173806
• Product Code: NBH
• UDI-Device Identifier: 03596010129024
• UDI-Public: (01)03596010129024(10)50697610
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

2 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: 4356
• Device Catalogue Number: 4356
• Device Lot Number: 50697610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0