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

Model Number 72200829

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2018

Event Type  malfunction  

Event 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.

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 using the torque watch gage for obturator locking torque, device was found to meet print specification.This investigation could not identify any evidence of product contribution to the reported complaint for the initial mdr in the tab, read correctly (b)(4) 2018 instead of (b)(4) 2018.

• Brand Name: CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV
• 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: 7715139
• MDR Text Key: 115098519
• Report Number: 1219602-2018-00923
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010573520
• UDI-Public: (01)03596010573520(10)50713836
• Combination Product (y/n): N
• 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,health
• 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: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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