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

Catalog Number SY-2000-01

Device Problems Defective Device (2588); No Apparent Adverse Event (3189)

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The firm received the returned device from the distributor, and 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.

Event Description

An illuminoss distributor reported that during a procedure, the light box foot pedal would not activate the light box.An alternative method to activate the light box was used.The light box functioned correctly, the procedure was completed, and the patient outcome was good.

Manufacturer Narrative

At the time of the initial 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 the device manufacture date.An update on the progress of the on-going investigation and product evaluation activities the firm is performing.At the time of this followup 1 mdr report, the investigation into the cause of the event is still ongoing.The firm reviewed the manufacturing records for the device, and found the device met specification at the time of manufacture and release.The firm received the returned device from the distributor, and began 3 rounds of product evaluation to replicate the failure mode reported.Round 1: in house product evaluation on the returned device was performed on 17feb2023.These preliminary results could not replicate the reported failure mode (the foot petal activated the light box).The firm interviewed the distributor who reported this event, to get more information.Through these interviews, the firm clarified the sequence of events as experienced by this distributor.Round 2: in house product evaluation was performed again on the returned device, to attempt to replicate the failure mode based on the clarified sequence of events experienced by the distributor.These preliminary results could not replicate the reported failure mode (the foot petal activated the light box).Round 3: the device was sent to the firm's device contract manufacturer for additional product evaluation, to attempt to replicate the failure mode, and perform a complete diagnostic of the device.The contract manufacturer provided the firm with its initial analysis on (b)(6) 2023, which included that the device failure mode has not yet been able to be replicated.The contract manufacturer will therefore perform a final round of additional testing to verify if this reported failure mode can be observed.A follow up mdr will be submitted when further information is known about this case.

Manufacturer Narrative

At the time of the previous mdr submissions for this event, the investigation into the cause of this event was still underway.This followup mdr is to submit new information, including the results of the firm's product evaluation and root cause investigation.The firm received the returned device from the distributor, and performed 3 rounds of product evaluation to replicate the failure mode reported.Round 1: in house product evaluation on the returned device was performed on (b)(6) 2023.These preliminary results could not replicate the reported failure mode (the foot petal activated the light box).The firm interviewed the distributor who reported this event, to get more information.Through these interviews, the firm clarified the sequence of events as experienced by this distributor.Round 2: in house product evaluation was performed again on the returned device, to attempt to replicate the failure mode based on the clarified sequence of events experienced by the distributor.These preliminary results could not replicate the reported failure mode (the foot petal activated the light box).Round 3: the device was sent to the firm's contract manufacturer for additional product evaluation, to attempt to replicate the failure mode.The contract manufacturer provided the firm with its analysis and results, which concluded that the device failure mode has not been able to be replicated.The contract manufacturer performed a complete diagnostic of the device, and found that the unit passed all inspection testing, and functioned as normal.The firm on the basis of this evidence therefore concludes that there is nothing faulty with the unit.Review of ifu the instructions for use includes instructions to connect the foot pedal to rear of the light source console with an illustration of the back of the light box and arrow pointing to the foot pedal tubing insertion point., and also to operate the light source console by depressing the foot pedal.Potential sources of user error which could have led to this complaint include failure to plug the foot pedal tubing into the light box, or failure to depress the foot pedal to activate the light source.Followup interviews with the distributor who was present for this case do not indicate that these possible user errors were experienced in this case.The distributor is experienced with the illuminoss system and the light box, and described the correct user of the device when describing this case.Conclusion the root cause of this issue could not be definitely identified with the information available to the firm.Product evaluation found the device performs as intended, and the reported issue could not be replicated, either by the firm or the firm's contract manufacturer for the device.Although possible causes of this issue could have been user error, there is no evidence to suggest that user error occurred in this case.Therefore the cause is undetermined.

• 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: 16402257
• MDR Text Key: 310001464
• Report Number: 3006845464-2023-00006
• 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,Followup
• Report Date: 05/05/2023

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: 01/26/2023
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 01/20/2023; 01/20/2023
• Supplement Dates FDA Received: 04/12/2023; 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female