MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C GUIDED ANGLE AWL

Model Number T066-0061

Device Problem Bent (1059)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

The awl was found to be bent at the distal tip, it is not known if this was due to the patient's hard bone or the surgeon's failure to use the guided instrumentation that must be used with this system.

Event Description

During a revision surgery to remove non x-spine cervical plate and replace it with irix-c implant on adjacent levels, there were complications with hard bone.The surgeon used several tools to try to start a pilot hole; the freehand awl was bent, the guided angled awl was broken, a 14mm drill was bent, a 14mm drill was broken, and one straight awl was bent.There were no patient injuries due to the broken and bent instruments.Surgeon was able to start a pilot hole with a self-drilling screw after several attempts.

• Brand Name: IRIX-C GUIDED ANGLE AWL
• Type of Device: AWL
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• Manufacturer Contact: kriss anderson ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 6645779
• MDR Text Key: 77702839
• Report Number: 3005031160-2017-00140
• Device Sequence Number: 1
• Product Code: HWJ
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: T066-0061
• Device Lot Number: 67629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR