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

Model Number USSL-2213260

Device Problem Gas/Air Leak (2946)

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

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Dhr review: a review of manufacturing records fouund that the device met specification at the time of manufacture and release.Followup information provided by the user: while preparing the implant and negative prepping the balloon, the scrub tech was removing the syringe and turned the syringe further clockwise overtightening the syringe.The syringe was then removed properly.While attempting to wet prep the balloon, it was noted that there was a great deal of air in the system.While drawing a vacuum to remove the air and monomer, it was noted that air was continually entering the system.The illuminoss rep at the case reported that the luer of the stopcock may no longer have been airtight.The implant was not used.A second illuminoss implant was opened, prepped according to the ifu, and utilized.The procedure was completed as planned and the patient was not affected.Returned product evaluation: the information provided by the reporter identified a possible cause for the malfunction as the seal integrity between the device's stopcock and the syringe used.It was reported that the syringe had been overtorqued when attaching it to the catheter's stopcock, which could contribute to the syringe's ability to make a tight seal, thus making it difficult to evacuate all air from the balloon.The returned device was received at the firm on june 1, 2020.It was received intact, with light fiber still inside, inside its original packaging.The syringe that was used as the evacuation syringe during the case was also returned.After removal from the packaging, the luer of the stopcock was checked for seal integrity using the syringe.The integrity check included filling the syringe with air, attaching it to the luer of the stopcock, submerging the stopcock and syringe under water in a water bath, and pushing down on the syringe's plunger to create pressure.If the luer of the stopcock was stripped due to the overtorquing by the user, bubbles would be observed in the water bath.After several attempts pressurizng the connection, no bubbles were observed.This indicated that the stopcock's luer was not damaged.Because the monomer that had been injected into the balloon assembly during the preparation of the catheter had polymerized, it was not possible to verify via leak test whether there was a hole in the catheter's stem or in the balloon itself.There were no obvious holes or tears in the balloon upon visual examination.Ifu review: instructions for use inclde the device preparation steps performed by this user in this case, to "evaluate all of the air out of the implant".The reported failure mode was not able to be replicated.Based on the product evaluation testing, there does not appear to have been an issue with the seal integrity between the stopcock and syringe.This failure mode could have been caused by the luer and the syringe not being fully engaged by the user, or by a small hole or tear in the balloon, too small to be observed by visual inspection.Because of the cured monomer inside the balloon and the catheter stem, further leak testing of the balloon catheter and balloon was not possible, so the cause of this malfunction could not be determined.Conclusion: the investigation was not able to identify a root cause for this malfunction.Therefore, the root cause is undetermined.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.On (b)(6) 2020, a procedure involving the fixation of the left humerus with the illuminoss implant and a plate was completed on a 57-year-old male patient.He was in stable condition throughout the procedure.While preparing the implant and negative prepping the balloon, the scrub tech was removing the syringe and turned the syringe further clockwise overtightening the syringe.The syringe was then removed properly.While attempting to wet prep the balloon, it was noted that there was a great deal of air in the system.While drawing a vacuum to remove the air and monomer, it was noted that air was continually entering the system.The implant was discarded and not used.Another illuminoss implant wassuccessfully prepped and implanted.The procedure was completed as planned and the patient was not affected.

• 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: 16812204
• MDR Text Key: 314004054
• Report Number: 3006845464-2023-00016
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132600
• UDI-Public: M986USSL22132600
• 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: 04/25/2023

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 Expiration Date: 05/31/2023
• Device Model Number: USSL-2213260
• Device Catalogue Number: USSL-2213260
• Device Lot Number: 390368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic