MAUDE Adverse Event Report: SAFEWIRE LLC YWIRE 1.40 MM; YWIRE 1.40MM

Model Number ]][

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/14/2012

Event Type  No Answer Provided  

Manufacturer Narrative

Safewire, llc assets have been sold to a large medical device manufacturer.Their request is for all device / patient complaints to have a mdr completed.According to safewire procedures this complaint didnt warrant a mdr to be completed as it didnt impact the patient by surgical intervention, death or serious injury.

Event Description

Upon the completion of surgery, the surgeon reported he noticed the "y" tip of the ywire had broken.No indications were given how the wire broke.

• Brand Name: YWIRE 1.40 MM
• Type of Device: YWIRE 1.40MM
• Manufacturer (Section D): SAFEWIRE LLC; 8963 stiriling rd; suite 7; cooper city FL 33328
• MDR Report Key: 5489882
• MDR Text Key: 40259871
• Report Number: 3008595221-2015-00003
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/23/2015

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: No Information
• Device Model Number: ]][
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other