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

Catalog Number USSL-2213260

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

This complaint describes a leak between the y-connector of the delivery system and the flow tube, during the process of infusing monomer through the delivery system to the implant which was placed in the intramedullary canal of the humerus.This part of the catheter and delivery system are bonded together during the manufacturing process, and remain external to the body.This observed failure of the bond between the y-connector and flow tube is confirmed to have caused the leak of monomer outside the patient, and was not related to a breach in the balloon itself.The company representative who observed the procedure noted that the user had infused the first syringe of monomer into the implant without issues, and much of the second syringe.The representative noted in an interview that dr.(b)(6) had reached a point where the infusion has slowed down, where the balloon appeared under fluoroscopy to be extended within the intramedullary canal to the walls of the canal, and where he was visibly expending effort to exert greater strength on the syringe plunger to continue the infusion, when the leak suddenly appeared.Engineering evaluated the image of the complaint device, a simulation of this failure mode with representative product, and the description of the timing of the failure.Engineering evaluation concluded that the y-connector bond with the flow tube was functioning properly during the initial procedure, and that it was this bond that failed during the procedure when the second syringe was being used to infuse monomer into the implant, causing the observed separation between the flow tube and the y-connector, which led to "liquid polymer spilt on the drape".There is no evidence of mis-use or mishandling in this event, which might have led to this failure mode.When asked for follow up information, the company representative reported that the user did not vigorously manipulate the catheter back and forth, or at great angles when placing the implant, nor pulled or tugged on the y-connector, although he did note that the treatment was a proximal humerus which required the implant path into the intramedullary canal to start with an angle.What is known about the procedure is in alignment with the instructions for use provided for this device.The use procedure described by the user and the company represent do not suggest that any mis-use was the cause of this failure.The manufacturing records for this device were investigated.These 2 components are bonded together during the manufacturing process as described in the manufacturing procedure, this step was completed for this lot per the instructions.There are two separate instances of inspection testing for this bond per the procedure.These were correctly performed, and the units of this lot passed these inspection steps.There were no nonconformance's associated with the manufacturing of this lot.The verification and validation testing for this element of the device was reviewed.Verification testing established the y-connector to flow tube bond tensile strength is greater than the strength of the isolated flow tube.The design validation for the molded y-connector bond strength with the flow tube documents the testing that established the y-connector to flow tube bond tensile strength is greater than the strength of the isolated flow tube, and passed the 30 newton strength requirement for this bond.This design verification and validation testing, and the manufacturing process followed, are designed to anticipate and support the proper functioning of the device (i.E.Maintenance of the y-connector to flow tube bond) when subjected to the forces of pressure anticipated from the 20 cc or 10 cc syringe depressed by the user to infuse monomer into the implant.The complaint device was not returned for product evaluation, and so further investigation into potential manufacturing cause could not be performed.A review of complaint history found no other complaints for this lot, nor any other complaints for this failure mode.The cause of this failure is unable to be determined.The device met manufacturing specifications at the time of manufacture, which are supported by design verification and validation testing for device use in the circumstances described in this case.There is no evidence of user mis-handling of the device that may have caused this failure.This is the first incidence of this failure mode reported to illuminoss, and this failure mode is captured in the fmea for this device.There was no patient impact.This type of complaint will continue to be monitored.

Event Description

During a prophylactic stabilization of right humerus performed on (b)(6) 2021, dr.(b)(6) experienced the following event: "during inflation of the balloon catheter, there was a burst in the plastic and liquid polymer spilt on the drape.A subsequent kit was opened and replaced the first." additional information was requested and received, including an image of the complaint device.Follow up information included that the procedure was completed using a backup device, that the procedure delay resulting from this event was approximately 10 minutes, and that , and that the patient outcome was good.There were no other complications.This complaint describes a leak between the y-connector of the delivery system and the flow tube, during the process of infusing monomer through the delivery system to the implant which was placed in the intramedullary canal of the humerus.This part of the catheter and delivery system remain external to the body.This observed failure is confirmed to have caused the leak of monomer outside the patient, and was not related to a breach in the balloon itself.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 11679577
• MDR Text Key: 245861355
• Report Number: 3006845464-2021-00006
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2021

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: 03/31/2024
• Device Catalogue Number: USSL-2213260
• Device Lot Number: 400276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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 Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 91