MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM

Catalog Number 826-211

Device Problem Material Fragmentation (1261)

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

Event Date 05/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device was returned to the manufacturer.Evaluation is in progress.

Event Description

It was reported that the patient underwent a procedure to treat spinal deformity.During placement of a cable implant around t3 lamina, the cable frayed at the end and a large piece of metal came off.The surgeon cut off the portion of the cable that was not used.The remaining portion left implanted was intact.No patient complications were associated with the event.

Manufacturer Narrative

Product analysis :visual review confirms cable breakage, with approximately 90 mm of cable missing from this side of the cable.Microscopic examination of the cable identifies bend in the cable with strand damage both above and below the breakage.The angle and location of strand breakage is consistent with the cable coming in contact with a sharp corner during tensile loading.Microscopic examination of the individual cable strand fracture surfaces reveal fairly flat fracture surfaces, with a surface angulation consistent with shear overload.Fracture surfaces containing varying degrees of damage and mechanical smearing.The above observations are consistent with shear overload.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLAS CABLE SYSTEM
• Type of Device: CABLE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4854382
• MDR Text Key: 22896955
• Report Number: 1030489-2015-01225
• Device Sequence Number: 1
• Product Code: ISN
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826-211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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