MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA SMOOTH FLEX 6.5 X 72MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72200428

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 10/24/2016

Event Type  malfunction  

Event Description

It was reported that fragments of the cannula broke in the patient.The pieces were removed using a graspher and shaver suction.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

• Brand Name: CANNULA SMOOTH FLEX 6.5 X 72MM
• 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 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6123630
• MDR Text Key: 60867827
• Report Number: 1219602-2016-01278
• Device Sequence Number: 1
• Product Code: NBH
• 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
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200428
• Device Lot Number: 428160624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1