MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ATLAS CABLE SYSTEM; WIRE, SURGICAL

Catalog Number 825-210

Device Problem Mechanical Jam (2983)

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

Event Date 06/24/2014

Event Type  malfunction  

Manufacturer Narrative

Additional information: evaluation found that the cable tensioner instrument cycles and operates properly.A cable is jammed within the instrument and is severely damaged.The cable is unable to be removed without damaging the instrument.The observations are consistent with misalignment of the cable during insertion into the tensioner.

Event Description

It was reported that a patient underwent posterior spinal fusion t4-t8.When using the tensioner for the cables, one of the cables became stuck in the tensioner.The surgeon was unable to remove the cable from the device and therefore does not work.The cable was cut and left in the patient.There was enough tension on the cable at that point and another tensioner was not needed.No patient complications were associated with this event.

Manufacturer Narrative

(b)(4): the device was not returned to the manufacturer for evaluation.

• Brand Name: ATLAS CABLE SYSTEM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea rd.; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3947131
• MDR Text Key: 11932192
• Report Number: 1030489-2014-03263
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 825-210
• Device Lot Number: 13907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1