MAUDE Adverse Event Report: SAFE WIRE, INC. SAFEWIRE Y-WIRE

Model Number FC-140-22-B-2

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/05/2014

Event Type  Injury  

Event Description

The end of the wire broke off flush in the s1 vertebra.Surgeon was unable to remove.The remainder of the wire was retrieved.No complications suspected.

• Brand Name: SAFEWIRE Y-WIRE
• Type of Device: Y-WIRE
• Manufacturer (Section D): SAFE WIRE, INC.; 8963 stirling road; suite 7; cooper city FL 33328
• MDR Report Key: 4277093
• MDR Text Key: 5031937
• Report Number: MW5039227
• Device Sequence Number: 1
• Product Code: HXI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: FC-140-22-B-2
• Device Lot Number: 82117787
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR