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

Model Number T066-0205

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Awl has not been received for evaluation.Answers to questions about the reported incident have not been received either.

Event Description

The tip of the awl was broken during a case.No additional information provided.

• 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: charlene brumbaugh ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 6926112
• MDR Text Key: 89940475
• Report Number: 3005031160-2017-00160
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: T066-0205
• Device Lot Number: EM12M005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other