MAUDE Adverse Event Report: SGARLATO MED LLC GAIT

Model Number 30 - 100 - 01

Device Problems Use of Device Problem (1670); Cut In Material (2454); Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Inflammation (1932)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

A sports doctor implanted a big toe joint into an infected bug toe in (b)(6) 2011.After several years of inflammation problems, the patient sought help at a wound care center.The wound care center sent the patient back to the sports doctor who removed the original implant and replaced it with an identical implant.The second surgery on the inflamed big toe took place on (b)(6) 2014.However, upon removal of the original implant, the doctor claims the implant had failed.Examination of the implant clearly shows that the implant was cut with a sharp instrument to remove it from the big toe.Examination by several other doctors confirmed that the sports doctor was responsible for the failure.

Manufacturer Narrative

Report incident was received by the manufacturing site on (b)(4) 2014.Information was gathered and an evaluation made to determine seriousness of this incident.It was determined to be a 30 day notification.Starting (b)(4) /2014, the latest 3500a form was required, but after various attempts to get this form off the fda web page, none could be found or opened on the fda site.After a call to fda on (b)(4) 2014, an email address was provided to assist in contacting someone to obtain a latest copy of form 3500a.It was determined that the fda site was inoperative and forms could not be obtained.After query, a copy of the form was sent by email on 02/18/2014.Fortunately, the adverse event was not critical so is being submitted within the required time frame.

• Brand Name: GAIT
• Type of Device: GAIT
• Manufacturer (Section D): SGARLATO MED LLC; 1975 hamilton ave.; suite 38; san jose CA 95125
• Manufacturer Contact: thomas lypka ; 1975 hamilton ave.; suite 38; san jose, CA 95125 ; 4086269600
• MDR Report Key: 3799690
• MDR Text Key: 21734759
• Report Number: 2939320-2014-00001
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30 - 100 - 01
• Device Catalogue Number: 30 - 100 - 01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report Sent to FDA: 02/25/2014
• Distributor Facility Aware Date: 02/03/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2014
• Date Manufacturer Received: 02/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR