MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDUILLARY FIXATION ROD

Model Number USSL-1700260

Device Problem Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

The device in question is an intramedullary balloon catheter (ibc) that is part of the illuminoss photodynamic bone stabilization system (pbss).It is a formed-in-place intramedullary implant used to stabilize bone fractures in much the same way as an intramedullary nail (imn) does.The ibc consists of a balloon attached to a catheter and y-body assembly that allows the user to infuse monomer material into the balloon to fill it once it is in the intramedullary canal and placed across the fracture site.The catheter and y-body also allow access for the light fiber into the balloon which provides the light necessary to harden the monomer into a polymer.The light fiber is connected outside the sterile field to a light source via a light guide, which when activated using a timer key provided with the pbss implant and delivery system, emits visible light that cures the monomer filled balloon in-situ, resulting in a permanent implant.The balloon, once hardened, is now able to stabilize the fracture during the healing process.In this instance, the doctor intended to use a plate for osteosynthesis, to treat the traumatic fracture of the femur, and also an illuminoss intramedullary implant to provide additional fixation for the screws, within the bone.The illuminoss photodynamic light curing system and light guide were returned for product evaluation.The implant was disposed of in the or and not available for product return and evaluation.The light box and light guide were returned to illuminoss and evaluated on april 25th, 2022 by engineering and quality.The light box product evaluation found the device performed within specification, and its light output was within specification.The light guide light output was measured and found out of specification and low.The light guide was examined for gross damage or kinks, and none were noticed.Both ends of the light guide were examined with a magnifying eye loupe and the optical taper end had a ring of clear plastic around the opening to the optical taper on the gold hub, obscuring over a portion of the optical taper where light is transmitted from the light guide to the light fiber of the implant.This ring of clear plastic on the gold hub appears to be melted light fiber.Another light guide was used with light box sn (b)(4) to measure the light output and it was in specification.The outer portion of the gold hub was detached from the rest of the returned light guide so the optical taper could be visualized.The melted ring of plastic was only present on the distal portion of the gold hub in a ring around the hole where light shines through from the optical taper.This suggests the light fiber of the implant melted at the distal end of the hole in the gold hub, so the light fiber was not likely extended too far from the optical body hub, or else it would have melted deeper in the gold hub or onto the optical taper.The ring of plastic on the gold hub of the returned light guide was removed using a small drill bit so that the light output of the light guide in combination with the light box (without the melted light fiber present) could be evaluated.The light guide output was then measured in specification.Therefore, the most likely cause of the curing failure was the light fiber melted into the gold hub in front of the optical taper of the light guide used, reducing light output of the light guide to the fiber, as well as reducing the transmission of light down the fiber to the monomer, which resulted in insufficient light transferred to the monomer to cure the implant.A review of manufacturing records for the implant, as well as the light curing system, found that these devices were within specification at the time of manufacture.Root cause investigation into the potential causes for a light fiber hub to melt when correctly attached to the light guide of the photodynamic light curing system was conducted, using a fish bone diagram to illustrate potential causes of an implant curing factor.The root cause of "light fiber melting" was identified as the cause of reduced light output of the light guide and reduced light transmission of the light fiber, which led to insufficient light delivered to the monomer and an under-cured implant.Potential causes of the light fiber melting were also identified, and some were eliminated through the root cause investigation.The causes eliminated include those related to the light curing system and its light guide.The remaining potential root causes relate to the either to the manufacturing of the light fiber portion of the implant, or to the presence of environmental debris on the photodynamic light curing system's light guide.These include "light fiber is not polished", "light fiber "hairs"", "environmental debris in distal end of light guide" and "light fiber in wrong position in hub".The singular root cause of the light fiber melting in this case could not be determined.Conclusion: the under-curing experienced in this complaint was due to the light fiber melting on the proximal end, which reduced the light transmitted from the light guide to the light fiber and thus to the monomer within the implanted balloon, which impacted the curing process.Although many causes can be ruled out, the root cause of the light fiber hub melting cannot be definitively determined, although it may be due to the light fiber being positioned too far out of the optical body, or to the presence of environmental debris in or on the optical surface of the gold hub at the time of use.

Event Description

On (b)(6) 2022, dr.(b)(6) of (b)(6) in the us intended to treat a 66-year old male trauma patient with a distal femur fracture with traditional plate and screw fixation, augmented with an illuminoss photodynamic bones stabilization system implant (17x260mm) as an augmentation to provide additional support within the affected bone.The fracture was reduced and illuminoss implant placed.During the curing process for the illuminoss implant, the rep noticed the light fiber coming from the light box to the balloon was not as bright as it usually is and the light on the back right of the box was not as bright was it normally was.When the user went to drill through the balloon for the next part of the planned procedure, the monomer came out, indicating that the implant had not cured.The user sucked out all the monomer, and decided to leave the balloon in place as the monomer had all been removed and the catheter already cut off.The user then decided to do a double balloon technique in the femur using a new implant sized 17x260mm and another new implant sized 22/13x240mm.The 22x13x240mm implant was cured with a second light box and cured successfully.The new 17x260mm implant was cured with the light box that was originally used in the above under-cured balloon, and was observed to have the same issue: the light fiber did not appear as bright as usual.After the cure time was completed for both implants, the user proceeded to perform an off-label procedure, whereby he removed the light fiber from both balloons, kept the light fiber from the 22x13x240 implant connected to the lightbox used to cure that implant and inserted it into the 17x260 implant.He then performed a second cure of the 17x260 implant, using the second light box.The rep noticed the light fiber lit up as bright as it normally does, and the light box seemed to be working appropriately.Later in the surgery when screws were added into the illuminoss implants, both implants were solid and cured.The rep returned the light box that appeared to be not as bright to illuminoss for investigation.The patient outcome was great, and the delay caused by the curing failure was 45 minutes.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 14432105
• MDR Text Key: 300303717
• Report Number: 3006845464-2022-00003
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL17002600
• UDI-Public: M986USSL17002600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2022

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: USSL-1700260
• Device Catalogue Number: USSL-1700260
• Device Lot Number: 390282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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
• Treatment: ILLUMINOSS LIGHT CURING SYSTEM, S/N (B)(4)
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: Asian