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

Model Number 4356

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2018

Event Type  malfunction  

Event 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.

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.

• Brand Name: OBTURATOR,INTEL 4MM A'SP FOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7726229
• MDR Text Key: 115411018
• Report Number: 1219602-2018-00943
• Device Sequence Number: 0
• Product Code: NBH
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1