MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; INVIVO INTRAMEDULLARY FIXATION ROD.

Model Number SY-2000-01

Device Problem Shipping Damage or Problem (1570)

Patient Problems Bone Fracture(s) (1870); Fracture, Arm (2351); Patient Problem/Medical Problem (2688)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

The issue that caused the complaint was a displaced light bulb inside our light box.The light bulb emits a specific wavelength of light at a specific level of intensity for a specific period of time in order to cure the monomer material infused into an implanted balloon device.Once the curing time has been achieved, the monomer becomes a polymer and hardens creating a rigid pin within the intramedullary canal of the bone.In this particular case, this did not occur due to the light bulb within the light box, being displaced as a result of loosening of the screws used to hold the light bulb in place.Because the light box is a durable goods device it will be exposed to vibrations caused by shipping the device from hospital location to hospital location.It is these vibrations that are being considered the most probable root cause of the screws loosening and the eventual displacement of the light bulb.To provide context for this complaint, this is the first and only incident of a light bulb being found displaced, since the light box was first placed on the market in europe in 2010.

Event Description

Complaint: monomer with the implant did not cure after the prescribed curing time was completed.Implant needed to be removed and replaced with another manufacturers nail.Details of procedure: female patient with lesion of unknown origin in right mid-shaft humerus was scheduled for im nail implant with illuminoss photodynamic bone stabilization system.The compromised bone was in an advanced state causing the bone to fracture during the prepping and positioning portion of the case preoperatively.The physician gained a minimally invasive access point just lateral to the rotator cuff structures on the right humerus per our procedure guidelines.The physician followed all prescribed procedural steps per the surgeons guide, to prepare the bone canal and the insertion of the implant.Monomer was infused into the balloon implant until the physician met resistance and could no longer infuse more monomer.Images were taken and implant position was verified prior to activation of the light source.The light fiber was handed off the sterile field and inserted into the light guide prior to activating the light box.The light box was set to the proper timing based upon the time card inserted.The foot pedal switch was activated to start the curing process.The curing process ran its course for 1,000 seconds and the light box deactivated at the completion of the time.The physician completed the final steps and upon separation of the tail, they noted that liquid monomer began to ooze out of the proximal incision site.The surgeon determined the implant did not fully cure and decided to remove the entire balloon implant.An approximately 6-inch incision was made on the lateral aspect of the upper arm to gain access to the active fracture site.The balloon implant was separated in two and the proximal portion of the implant was removed from the im canal.The physician removed the distal portion of the balloon from the distal humerus.The physician then took steps to place a synthes intermedullary nail.The case was complete and the patient incision closed.

Manufacturer Narrative

The purpose of this follow-up report to the initial report (3006855464-2019-00003), is to correct an error made in section h 7.Illuminoss had incorrectly identified that there was remedial action taken (correction/adjustment) to address an issue found with respect to a returned light box.It was learned after a recent fda inspection where the issue of whether the event should have been reported as a 5 day report or a 30 day report, that this event was incorrectly identified in the mdr.This discussion led to a review of the 'medical device reporting for manufacturers' guidance document, which states that the fda does not consider an action taken to correct only a single device involved in a mdr reportable event to be a remedial action.The device reported in the mdr was the only device that needed adjustment with no other devices needing a similar adjustment and no trend of this occurrence to indicate any remedial action is necessary.Therefore, no option within section h 7 should have been selected.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: INVIVO INTRAMEDULLARY FIXATION ROD.
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC.; 993 waterman ave; east providence RI 02914
• MDR Report Key: 8394041
• MDR Text Key: 141472455
• Report Number: 3006845464-2019-00003
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY-2000-01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ILLUMINOSS DEVICE
• Patient Outcome(s): Required Intervention