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

Model Number T066-0205

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

Awl was disposed of by hospital, not returned.Device disposed of.

Event Description

The surgeon was using the guided angled awl on the c5 level, as he was hammering the pilot hole into the vertebral body he could see under fluoroscopy that the awl tip had sheared off.The awl shaft was removed from the surgical site and tip remained in c5 vertebral body.A pair of needle drivers were used to remove the awl tip from surgical site with no harm done to the patient.The awl tip and shaft were disposed of due to sharp edges and patient health history.

• 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: 6244245
• MDR Text Key: 64578059
• Report Number: 3005031160-2017-00109
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: T066-0205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 113