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

Model Number 100156-57

Device Problem Material Too Soft/Flexible (4007)

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

Event Date 03/08/2022

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 intrameduallry implant to provide additional fixation for the screes, within the bones.Both the implant, as well as the illuminoss photodynamic light curing system, were returned for product evaluation.The light box, light guide, and foot pedal were returned to illuminoss and evaluated on (b)(6) 2022 by engineering and quality.(b)(4) "returned product evaluation" for an in-depth description of the evaluation and images of the optical taper.The returned product evaluation determined the light box has light output was within specification, but the light guide output was significantly lower than the acceptable range.The optical taper in the gold hub was discovered to have debris on the taper, blocking the light.The gold hub was disassembled and debris removed, then retested.The light guide output was found to be in specification.It was determined that whatever had caused the debris to be on the optical taper of the light guide, which blocked some of the light and reduced the light output of the light guide to the implant, caused insufficient light to be delivered to the light fiber to cure the implant, resulting in an under-cured implant.The implant (with light fiber and optical body hub components attached) was returned to illuminoss and evaluated on april 26, 2022 by quality and engineering after decontamination at exponent.(b)(4) "returned product evaluation" for in depth-imaging, description, and evaluation of the light fiber and optical body hub.The light fiber was severely melted and burned at the proximal end which interfaces with the light curing system's optical taper hub to transfer light from the light guide to the implant to cure the monomer.The melted and burned light fiber is the likely cause of the debris on the optical taper which may have been pieces of burned light fiber or deposited particles due to the potential smoke created from the plastic melting and burning.The melted light fiber would not transmit light effectively from the light guide down the length of the fiber and therefore the monomer would not receive enough light to fully cure.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" causing debris on the optical taper and reduced light output of the light guide and reduced light transmission of the light fiber causing insufficient light delivered to the monomer and an uncured implant was identified as the cause.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, because the light curing system had an in specification light output reading, and the light guide had an in specification light output reading once the debris was cleaned off, and the manufacturing record review showed the light box was released in specification at the time of manufacture and release with the light guide it was returned with.The remaining potential root causes relate to the manufacturing of the light fiber portion of the implant.These include "light fiber positioned incorrectly in hub", "unpolished fiber end", and "light fiber hairs".A specific root cause could not be determined.The most probable root cause of the light fiber melting is due to the "light fiber positioned incorrectly in hub" because the melting of the fiber was so significant, and debris was deposited on the face of the optical taper (which is set back inside the gold hub) as supposed to melting or depositing debris on the gold hub itself, which indicates the light fiber was too far out of the optical body and thus when inserted into the gold hub was too close to the optical taper and melted, leaving debris on the optical taper face.Conclusion: the under-curing experienced in cir-0149 was due to the light fiber melting on the proximal end resulting in reduced light transmission of the fiber, and causing debris on the optical taper, which together reduced the light transmitted from the light guide to the light fiber and thus to the monomer within the implant 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.

Event Description

On (b)(6) 2022, dr.(b)(6) of (b)(6) hospital (b)(6) intended to treat a (b)(6) male dementia patient with a traumatic femur fracture with traditional plate fixation, augmented with an illuminoss photodynamic bones stabilization system implant as an augmentation to provide additional support within the affected bone.The fracture was reduced and illuminoss implant placed.After the curing process for the illuminoss implant, before the next step in the planned procedure to add the plate, the doctor identified that the implant had not cured and was not sufficiently hardened.He removed the illuminoss implant from the bone, flushed the site with water, and then successfully completed the procedure with only the plate.

• 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; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 14254837
• MDR Text Key: 290457466
• Report Number: 3006845464-2022-00002
• Device Sequence Number: 1
• Product Code: QAD
• 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: 04/29/2022

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: 05/31/2024
• Device Model Number: 100156-57
• Device Catalogue Number: 100156-57
• Device Lot Number: 400699R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 55 KG