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

Catalog Number SL-2213260

Device Problem Gel Leak (1267)

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/19/2022

Event Type  Injury  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.The user was treating a patient with a pathological humerus fracture as a result of a fall, using illuminoss implant and screws on (b)(6) 2022.The patient is a 78 year old male, 70kg, 177cm tall (154lbs, 5.8ft) with comorbidities (metastatic prostate ca, dmii (type 2 diabetes), and hypertension).The user noted the implant could not maintain a vacuum during balloon preparation, but at the time he was not aware that this indicated a leak in the implant.The user inserted the implant, infused it with monomer, and covered the entry site with a wet compress.The user then cured the implant.During this process the user noticed what looked like monomer had leaked out, so the user rinsed the wound with plenty of water.After curing, the user added anti rotation screws.On february 19, the user had to see the patient again to treat a wound infection using radical debridement, mechanical cleaning, rinsing and gentamicin chain application.The implant remains implanted in the patient.

Manufacturer Narrative

Returned product evaluation: the product was not available for evaluation as it remains implanted.Dhr review a review of the manufacturing records associated with this implant was conducted.Special attention was paid during the dhr review for sterility operations and leak testing operations.18 pieces of the pouched assembly passed the final leak test and 2 failed.The 2 units that failed were scrapped.All units that were released with this dhr met their final release specification for leak testing at the time of their release.The sterility test reports for the monomer and the sterility test certification for the pouched implant and delivery assembly verified the sterility of those runs.All product was in specification at the time of manufacture and release and there is no indication manufacturing contributed to this complaint.Information from the doctor: the user stated the infection could be explained by the patient's reduced immune system due to type 2 diabetes and the compromised post-traumatic soft tissue conditions.The user stated that he followed all the surgical steps for the illuminoss photodynamic bone stabilization system, but noted that during device preparation the balloon could not be fully deflated (a vacuum could not be maintained during device preparation).Per the manufacturer's instructions for use, the user should have discarded and replaced with a new implant prior to implantation because if the implant cannot hold a vacuum during device preparation, it likely has a leak or is damaged in some way and may not contain the monomer during the inflation.In this case, the user continued using the implant and inserted it as usual, infused it with monomer, and cured it.During this process, the user noticed that monomer had leaked out.The user stated in retrospect the syringe plunger not fully retracting during the balloon preparation could be indicative as the balloon having a leak, but they were unaware of that at the time.Illuminoss will further investigate this user comment separately within its post market surveillance system to confirm that any potential related use errors are correctly addressed in the illuminoss photodynamic bone stabilization system risk management file.Review of risk of patient infection this mdr investigation focused on the ways the device could have caused or contributed to the adverse event (infection), which is related to the sterility of the implant and delivery system, the leaked monomer, and illuminoss surgical instruments.The illuminoss photodynamic stabilization system is composed of several parts supplied sterile, as well as reusable instruments which are cleaned and sterilized at the hospital.The implant kit and delivery system are sterilized via eto overkill.The most recent sterilization validation was reviewed and demonstrated a sterility assurance level of 10-6.The monomer is sterilized via filtration and aseptic vial filling of autoclave sterilized vials which are then placed inside pouches which have been gamma sterilized.The most recent sterilization validation of the aseptic filtration process of the monomer was reviewed and found the filtration and filling process is considered validated since documented evidence has established the process will produce the desired results consistently, within the specified acceptance limits, when performed as per the latest sops.In addition to the monomer aseptic filtration process validation, each lot of monomer aseptically filled is tested for sterility and a sterility report is provided.The most recent foil pouch sterilization validation was reviewed and demonstrated a sterility assurance level of 10-6.Therefore, all components provided sterile have been sufficiently validated and there is no indication insufficient sterilization validation of the device contributed to this complaint.The cleaning and sterilization validation for the illuminoss reusable instrument sets, cleaned and sterilized by the hospital, was reviewed, and found that the cleaning and sterilization methods for the reusable instruments have been validated.Illuminoss clinical and medical affairs noted there are many potential causes of wound infection during surgery that are not device related, including improper sterile field management of or, improper aseptic technique of surgical staff, improper preparation of surgical site pre-op, improper care of surgical site post-op, or reduced immune function of patient and soft tissue trauma during surgery.Illuminoss clinical affairs provided information for this investigation from clinical evaluation reports.This report identified a 2.2% wound infection rate for the illuminoss implant.This is within the range noted to be 0-12% for comparative procedures (plates, screws, and im nails).A 6.9% wound complication rate which may or may not have been related to the illuminoss device was also noted, which is below the rate of non-infection wound complications for orthopedic and trauma surgery (59%) per uckay et al., in noninfectious wound complications in clean surgery: epidemiology, risk factors, and association with antibiotic use.The rate of clinical infection and non-infection wound complications for illuminoss implants are within the anticipated range for these types of orthopedic procedures.Complaint review complaints from the previous 12 months, february 23, 2021-february 23, 2022, were reviewed for other instances of wound infection and found that there were no other complaints related to patient wound infection.Review of ifu instructions for use and surgical technique guides were reviewed for instructions for the user if the balloon cannot hold a vacuum during balloon preparation, as well as for the risk of infection.Instructions on the proper device preparation steps, and what to do if a balloon cannot hold a vacuum during device prep is described.The risk of infection is described, which exists for use of any im fixation system.Conclusion the root cause of the implant leaking is unknown.There are several potential causes of this failure mode, but as returned device evaluation is not possible as the device remains implanted, and the manufacturing records indicate the device met specification at the time of release, the root cause could not be determined.The root cause of the patient wound infection is unknown.The leaking implant was ruled out as a cause of the patient infection because the monomer was supplied sterile, so the leaked monomer is unlikely to have introduced any bacterial contamination which may have led lead to an infection.The sterility of the implant delivery kit was ruled out as a cause of the patient infection, as the implant and delivery components of the device were provided sterile.The illuminoss instruments are provided with validated sterilization instructions.It is possible that the patient infection was contributed to the patient's reduced immune function due to type ii diabetes in combination with the soft tissue damage caused by the surgery.There are several potential causes of this failure mode, but it is difficult to determine the root cause of a patient wound infection after surgery as there are many potential sources of contamination to the sterile field or post-operative wound.

Manufacturer Narrative

A ·supplemental evaluation for mdr reportability was performed for this event, and determined that this is a serious injury mdr.

• 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; 4017140008
• MDR Report Key: 15738623
• MDR Text Key: 307568207
• Report Number: 3006845464-2022-00013
• 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: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: SL-2213260
• Device Lot Number: 400973
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG