MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; ACCESSORIES,ARTHROSCOPIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided as it becomes available.No evaluation conducted to date as product has not been returned.

Event Description

The patient sustained burns to his upper thigh during surgery.They are trying to rule out what is could be they have asked if it could have been the light lead or scopes.The consultant feels that is is most likely a diathermy burn.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.

Manufacturer Narrative

New information has been provided by the customer.Ssc conducted a full investigation and has concluded that smith-nephew equipment had nothing to do with the reported ae.

• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: james gonzales ; 7000 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6149097
• MDR Text Key: 61557228
• Report Number: 3003604053-2016-00119
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/24/2017; 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1