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

Catalog Number ML-08100

Device Problem Gel Leak (1267)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

During a procedure in germany to treat a metatarsal fracture with an illuminoss implant [size 8mmx100mm], a leak was identified.The user removed the illuminoss balloon, washed out the canal, and placed a new illuminoss balloon.The procedure was completed successfully, and 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 product is being returned from germany to the firm for device evaluation.At the time of this mdr report, the device remains in transit to the firm's decontamination service provider.A review of the manufacturing records for the device used in this case was performed and found that the device met its final release specifications at the time of manufacture and release.A review of complaints found no other complaints for this lot number.Followup information has been requested of the user.Product evaluation is anticipated but not yet begun, and a followup mdr will be submitted when further information is known about this case.

Manufacturer Narrative

Manuafacturer'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 and conclusions codes - manufacturer's narrative with the firm's root cause conclusions.Followup information from the user: additional followup information was requested and received from the user.The user reported that the device was able to draw a vacuum during device preparation, indicating that a leak was not present at the time of device preparation.The user reported that the balloon and/or lightfiber was not bent or inserted at a sharp angle.The balloon was advanced under fluro vision and the position corrected ("moved in place").The user further reported that the leak was experienced mid-way during the filling process, when a sudden loss of pressure or less resistance was observed, and the leakage then observed.Returned product evaluation the product was returned from germany to the firm's decontamination service provider on august 22, 2023.The firm received photoducumentation report for the device on august 28, 2023, and received the physical device for further in-house evaluation on september 6, 2023.In-house product evaluation was unable to determine the cause of the user experiencing a leak at the point of connection between the balloon catheter and the balloon components during the implant infusion process.Due to the condition of the returned device as provided to the firm by the user, the exact condition of the device at the time the leak occurred could be determined by evaluation of the returned device, which limited the ability of the product evaluation to make definitive findings.This product evaluation identified that a possible cause of the reported leak could have been a break in the seal between the balloon and flow tube components, however due to the limitations described above, the cause of a possible break in the seal could not be determined.Dhr review the manufacturing records for the device in question were reviewed and found that the device was in specification at the time of manufacture and release.The device passed its final leak test, and the balloon catheter adhesive used in the catheter assembly was conforming and within its use by date.Conclusion the device was able to hold a vacuum during device preparation, indicating that there was no leak at the time the device was being prepared for use.The user stated the leak occurred halfway though the monomer infusion process.Therefore, the leak occurred at some point between device preparation and halfway through the monomer infusion process.There is no indication that user error contributed to this failure, as the user reported that no unusual bending or handling of the device occurred during prep or placement.Manufacturing records indicate that the device was in specification at the time of manufacture and release.Although the returned product evaluation was able to identify that the leak may have originated from the seal between the balloon and flow tube components, the product evaluation was not able to make definitive conclusions about the condition of the device at the time the leak occurred, nor the cause of a possible break in the seal.Therefore, the root cause of the device leak is unknown.

• 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 providence, RI 02914 ; 4017140008
• MDR Report Key: 17566911
• MDR Text Key: 321371730
• Report Number: 3006845464-2023-00041
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/25/2023

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: ML-08100
• Device Lot Number: 430058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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 Ethnicity: Non Hispanic
• Patient Race: White