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

Model Number USSL-1100220

Device Problem Material Too Soft/Flexible (4007)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

On (b)(6)2022, an (b)(6) year old female was treated for a right humerus pathologic mid shaft fracture.The planned procedure was to use an illuminoss implant, and then plate and screws.After the curing cycle had been completed for the illuminoss implant [size ussl-1100220], the doctor found that the monomer had not fully cured.The implant was removed and replaced with another successfully, then the additional plate and screws were added.The patient outcome was good.

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The firm has conducted a review of the manufacturing records for the device in this case, and found that the device met specifications at the time of manufacture and release.The firm has conducted a follow-up interviews with the distributor who was present for the case, and collected additional information about the implantation procedure.On (b)(6)2022 the firm received a picture of the defective device from the distributor, and requested device return for product evaluation.This device was shipped to the firm's supplier for device decontamination, received at the decontamination site on (b)(6), 2022.The firm anticipates receipt of the device in order to perform device evaluation in order to complete the complaint investigation.A follow up mdr will be submitted when further information is known about this case.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.The firm has conducted a review of the manufacturing records for the device in this case, and found that the device met specifications at the time of manufacture and release.No other complaints have been received for this lot.Follow-up interviews: the firm has conducted a follow-up interviews with the distributor who was present for the case, and collected additional information about the implantation procedure.The user prepared the implant and inserted the balloon into the bone, the monomer was infused after the bone was reduced, the light fiber was plugged into the light box and light box activated and blue light came on.There was a piece of bone missing so the blue light could be seen shining in the balloon.After the cure time was completed the surgeon moved the patient's arm to check the fixation and the fracture was not solid.The surgeon checked the implant and it was still soft.The user removed the undercured implant, washed the bone canal thoroughly, then took a new illuminoss implant and inserted it into the bone.They plugged the second implant's light fiber into a different light box than was originally used and activated the light, and the implant cured successfully.The patient outcome after the case was fine.The distributor observed that the light coming out of the 2nd implant's light fiber during use was visibly brighter than the first implant's light fiber, which didn't cure.Using the light fiber portions of the 2 implant delivery systems that were removed from the implants after implant curing, per device use instructions, they performed the following checks: they plugged the light fiber from the 2nd implant which did cure into both light boxes, and they plugged the light fiber from the 1st implant which did not cure into both light boxes.They observed that the light from the light fiber from the 2nd implant appeared equally bright in both light boxes.The first light fiber from the undercured implant appeared significantly less bright than the second light fiber used, in both light boxes.Product evaluation on 07dec2022, the firm received a picture of the defective device from the distributor, and requested device return for product evaluation.This device was shipped to the firm's supplier for device decontamination, received at the decontamination site on december 5th, 2022.The report for the device decontamination and imaging was received by the firm from the decontamination vendor on 18jan2023.The device itself was received by the firm on 25jan2023, and product evaluation was performed.The returned product evaluation eliminated several potential causes of insufficient light output by the light fiber, including debris on the proximal end of the light fiber, damage of the light fiber hub, incorrect depth of the light fiber in the hub, or an insufficiently polished light fiber face.The returned product evaluation demonstrated that the root cause of the insufficiently cured implant was due to bending of the light fiber proximal to the start of the spiral cuts, which reduced the amount of light transmitted down the light fiber to be released to cure the implant.As the light fiber assembly passed its light output inspection requirements during device manufacture, the light fiber damage was not present at the time of manufacture and release.The most likely cause of the bending was therefore due to mishandling by the user.Review of ifu and review of potential user error: the surgical technique guide includes the instructions "avoid damage to the small diameter plastic light fiber extending from the rear of the implant as this delivers light to cure the implant.Do not severely bend or kink the light fiber, catheter or balloon implant.Handle components with care.Severe bends or kinds in the light fiber assembly will substantially reduce the light intensity delivered to the implant causing incomplete hardening of the liquid monomer.Do not pull or tug on the light fiber or place the light fiber under any strain when attaching it to the light guide.Do not apply instruments or clamps onto the light fiber and avoid contact with sharp objects.Damage to the light fiber may result in fiber breakage or a significant reduction in the light intensity to the implant resulting in incomplete hardening of the liquid monomer." instructions are provided in the labeling to not bend or kink the light fiber as this can result in an insufficiently cured implant.Inadvertent user error by mishandling the light fiber causing bending and damage is the most likely cause of this event.Conclusion: based on the description of the events from the user and distributor, the cause of the insufficient curing of the implant was due to insufficient light output from the light fiber, not due to the performance of the light box.This conclusion is also supported by the returned product evaluation which determined there were two bent sections in the light fiber resulting in excess light being lost in this area due to the light fiber damage.The most likely cause of the bends and damage to the light fiber is due to mishandling during use, as the light fiber passed its light output inspection requirement and therefore was not damaged at the time of manufacture and release.

• 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: 15934089
• MDR Text Key: 307903325
• Report Number: 3006845464-2022-00022
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL11002200
• UDI-Public: M986USSL11002200
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: USSL-1100220
• Device Catalogue Number: USSL-1100220
• Device Lot Number: 400281
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Asian