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

Manufacturer Narrative

The associated t handle was returned and evaluated.Our investigation included a visual inspection of the device which showed that the jaws of the t handle have fractured in two places.The fractured pieces were not returned.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The device was manufactured in 2013.The t-handle fractured in the jaws of the handle, likely from static bending or torsional overload.An overload fracture can occur if the mechanical loads applied to the device exceed the strength of the material.Our investigation did not determine a specific cause of the stated failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.

• 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: 4759386
• MDR Text Key: 5953566
• Report Number: 1020279-2015-00261
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization