MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INSTRUMENT; DELTA EFIX FRAME

Device Problems Detachment Of Device Component (1104); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported at one week post-op, the clamps of the delta frame had "sheered" off the carbon fiber bars and stripped from their fixation.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

• Brand Name: TRAUMA INSTRUMENT
• Type of Device: DELTA EFIX FRAME
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 9013995009
• MDR Report Key: 6221870
• MDR Text Key: 63848538
• Report Number: 1020279-2017-00013
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention