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

Catalog Number SY-2000-01

Device Problem Defective Device (2588)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

During a case to treat a distal femur fracture, in which the user planned to place 2 illuminoss implants and then plate and screws, the light from the light box was dim.The user switched to a backup light box instead.The illuminoss implant procedure was successfully completed, and then the user added plate and screws.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 follow-up interviews with the distributor who reported the product problem, to request additional information.On september 28th 2023, the firm received the returned device from the distributor.The firm is performing 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

Manufacturer's narrative at the time of the previous mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including product evaluation results of returned complaint device.The investigation findings codes.Investigation conclusion codes.And this manufacturer's narrative with the firm's root cause conclusions.Dhr review.A review of manufacturing records for this device found that it met specifications at the time of its manufacture and release.Returned product evaluation: product evaluation was able to replicate the reported failure of a dim light box.The light box itself was tested and found to be emitting light output per the specification.The light guide component of the light box was identified as emitting below specification light.The returned product evaluation identified a foreign material on the light guide distal hole which caused a reduction of light output.The foreign material was identified as most likely cured monomer, as the appearance, color, texture, and hardness are consistent with cured monomer.Followup information from the user followup information was requested and received from the distributor who reported this case.The distributor confirmed that the user verified that the implant had sufficiently cured with the backup device, and that when the surgeon placed the screws through the implant, they said the implant felt completely solid.The distributor confirmed that this light box had been used many times, but this is the first time he saw the faint blue light emitting from a light fiber during its use.The distributor did not report any unusual handling or usage of the light box or its components.The returned product evaluation identified a foreign material on the light guide distal hole which caused a reduction of light output.The foreign material is identified as most likely cured monomer.The formation of the ring of hardened material is consistent with a scenario in which the user introduced a few drops of liquid monomer to the distal end of the light guide, which then cured into hardned polymer upon activation of the light box.Per the instructions for use, there is no point during the system set up or use procedure in which liquid monomer is introduced to the light guide component of the light box, so the presence of the monomer cured onto the light guide indicates that the device was not used per the manufacturer's instructions.The ifu further instructs the user in the system setup instructions to "visually inspect both ends (of the light guide) to verify no foreign material is present." conclusion product evaluation identified that the cause of the reduced light output was due to a ring of foreign material on the inner diameter of the light guide, which is consistent with cured monomer, which may have been introduced in error to this light box component while in liquid form, and then hardened upon activation of the light box, leading to diminished light output.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDULLARY 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. proividence, RI 20914 ; 4017140008
• MDR Report Key: 17981115
• MDR Text Key: 326412799
• Report Number: 3006845464-2023-00042
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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 Catalogue Number: SY-2000-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1