MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON; INSTRUMENT

Model Number OR71364006

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 04/16/2015

Event Type  Injury  

Event Description

It was reported that surgery was delayed due to the instrument fracturing during surgery.Back up product was used to complete the surgery.

Manufacturer Narrative

• Brand Name: ECHELON
• Type of Device: INSTRUMENT
• 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: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 4759385
• MDR Text Key: 5792695
• Report Number: 1020279-2015-00260
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: OR71364006
• Device Catalogue Number: OR71364006
• Device Lot Number: 13GSY0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization