MAUDE Adverse Event Report: SAFEWIRE LLC YWIRE

Model Number YWIRE 110MM

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 11/12/2012

Event Type  malfunction  

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 didn't warrant a mdr to be completed as it didn't impact the patient by surgical intervention, death or serious injury.Device not returned to manufacturer.

Event Description

Upon the conclusion of a mis procedure it was determine that a ywire tip had broken.It was not determine at what point during surgery the wire broke.

• Brand Name: YWIRE
• Type of Device: YWIRE
• Manufacturer (Section D): SAFEWIRE LLC; 8963 stiriling rd; suite 7; cooper city FL 33328
• Manufacturer (Section G): SAFEWIRE LLC; 8963 stiriling rd; suite 7; cooper city FL 33328
• Manufacturer Contact: stephen inglese ; 8963 stirling rd; suite 7; cooper city, FL 33328 ; 8002869155
• MDR Report Key: 5490083
• MDR Text Key: 40260008
• Report Number: 3008595221-2015-00002
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/12/2012,11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2013
• Device Model Number: YWIRE 110MM
• Device Catalogue Number: FC 110-22-B-2
• Device Lot Number: 24590,26171,24589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2012
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2012
• Date Manufacturer Received: 11/12/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1