MAUDE Adverse Event Report: PARCUS MEDICAL GFS ULTIMATE; LIGAMENT RETENTION DEVICE

Model Number 10972

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Swelling/ Edema (4577)

Event Date 10/08/2020

Event Type  Injury  

Event Description

Per our records, this vigilance was originally submitted on 11mar2021.However, upon review of the maude database, it was determined that the report was not received by the fda.Therefore, we are resubmitting this report in its entirety as originally reported to the fda.Original submission narrative: 19 yo male patient underwent an acl reconstruction using a parcus medical gfs ultimate (part number 10972) for femoral fixation in chiclayo, peru on (b)(6) 2020.Roughly two months later, patient was experiencing: instability, swelling, pain, and an infection.On (b)(6) 2021, radiographs of the patient's knees were taken and the gfs implant body can clearly be visualized resting away from the cortical layer of the femur.Please see attached radiographs.On (b)(6) 2021, the distributor serving the customer in peru contacted parcus medical and a complaint file was initiated.At that time, the distributor indicated that the patient was being treated and was awaiting clearance to have a revision surgery to correct the failed repair.No additional information has been provided and the implanted device was not returned to parcus medical.

Manufacturer Narrative

Upon review of the radiographs taken on (b)(6) 2021, it was determined that the cause of the incident is due to improper placement of the implant.As described in the ifu provided with the gfs ultimate, the button and graft construct are passed through the prepare tunnel in the femur and then flipped so that the titanium button rests flush against the cortex of the femur.The radiographs clearly show a visible space between the implant button and the femur.Due to this space, it is evident that when the button was passed through the tunnel, it was pulled too far and therefore when it was flipped, it was caught up in the surround soft tissue.This is also consistent with the patient's post-operative experience as symptoms appear relatively soon after surgery.

• Brand Name: GFS ULTIMATE
• Type of Device: LIGAMENT RETENTION DEVICE
• Manufacturer (Section D): PARCUS MEDICAL; 6423 parkland drive; sarasota FL 34243
• Manufacturer Contact: paul vagts ; 6423 parkland drive; sarasota, FL 34243 ; 9417557965
• MDR Report Key: 15463360
• MDR Text Key: 300378776
• Report Number: 3007319107-2021-00001
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 10972
• Device Catalogue Number: 10972
• Device Lot Number: 13125
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male