MAUDE Adverse Event Report: SAFEWIRE LLC YWIRE

Model Number YWIRE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2010

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

Pedicle screw case - upon conclusion of the procedure it was found that the end of the ywire had broken off.This device part of lot 292-10 item 145ba22-4.The broken piece of ywire was no more then 5mm in length and no evasive procedure took place took place to remove the broken wire.

• 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: 5489812
• MDR Text Key: 40243757
• Report Number: 3008595221-2015-00001
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K 140576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Other
• 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: Physician
• Device Expiration Date: 11/01/2011
• Device Model Number: YWIRE
• Device Catalogue Number: 145BA22-4
• Device Lot Number: 292-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2010
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other