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

Model Number USSL-0700200

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/25/2022

Event Type  Injury  

Event Description

Illuminoss photodynamic bone stabilization system implants were implanted in the radius and ulna on the same side for a patient who had a midshaft break of both.11-12 days post op both implants broke and revision surgery was performed (b)(6) 2022 adding plate and screws.Further details: the patient broke both their radius and ulna on the same side, at the same point midshaft.On (b)(6) 2022 two illuminoss implants were used to treat both fractures (7x200mm diameter implants).The initial surgery went well and the implants had good cortical wall contact.The patient was doing well for 10-11 days post-op with no pain and no issue.On day 11 or 12, both implants broke at the location of the original bone fractures.Revision surgery was performed for the bone fractures of both radius and ulna on (b)(6) 2022 to add plates and screws.The illuminoss implants were left in the bone, and used to secure the additional plates and screws.The patient condition was reported as good, after the revision surgery.The patient was not given any post-operative immobobilization, restriction of movement or other stabilization instructions upon initial implantation with the illuminoss implants in the redius and ulna.The complainant reported that the patient's arms and implants only experienced normal forces from the patient using their arm for normal activities such as feeding themselves, and that the patient had no accidents nor performed any heavy lifting after initial implantation surgery.

Manufacturer Narrative

The investigation into the cause of this event gathered information from multiple data sources, and then used a "rule in / rule out" investigative approach to root cause analysis.An evaluation of the device was not possible, as it remains in the patient; the broken illuminoss medical implants were left within the bone, and used to secure plates and screws to, during revision surgery.A review of the manufacturing records was performed, and found that the product met manufacturing specifications at the time of manufacture and release.There is no indication that manufacturing contributed to this complaint.The instructions for use were reviewed and found that the risk of post-operative implant breaking is captured and ifu 900356_w, which states "as with any im fixation system or rod the following can occur: loosening, bending, cracking, fracture, or mechanical failure of the components or loss of or inadequate fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone, markedly unstable comminuted fractures, or insufficient initial fixation · loss of anatomic position with nonunion or malunion with rotation or angulation." at the manufacturer's request, the treating physician provided us with radiographs of the patient's treated ulna and radius, before initial implantation, directly after initial implantation, at the point where implant breakage was identified, and after revision surgery to add plates and screws was performed.A review of these radiographs performed by the manufacturer along with the manufacturer's medical oversight function.This review identified the following about this case: there is a combination of factors that would make these bone fractures more susceptible to stress and possible implant fracture, including the size of the implant thickness (small), position of the fracture of the ulna and radius at the same level, the segmental nature of the radius fracture (the radial neck is fractured without stabilization), and the lack of post-operative protection, such as a splint.The initial implantation treatment does not address the radial neck fracture visible in the radiographs, so the radius had a segmental fracture, which is even more unstable than if it was just the midshaft fracture.The implant thickness at the fracture location on the ulna is about 4-5mm thick, and a thicker implant would have provided more stabilization.A review of one of the x-ray images taken after initial implantation showed significant bowing in the radius and indicates potentially a poor fracture reduction, so even if the fractures had healed the patient's ability pronate/supinate would have been significantly inhibited.The manufacturer's medical oversight continued the analysis of the images and procedure information provided, and concluded that typical post operative care for a fracture like this could include a longarm posterior splint.Even if the fracture was fixed with the standard method of plates and screws, common medical care would be to utilize some additional stabilization or protection and to prevent pronation-supination, protect from pressure, and to promote healing until physical therapy can start.Therefore there may have been inadequate post-operative immobilization or care instructions in this case, as there was no form of immobilization, stabilization, or restriction of movement post-surgery.A risk review performed, and found that the failure mode of post-operative implant break is captured in the risk documentation for this device, with multiple potential causes.The anticipated severity for this failure mode was in line with the observed severity of revision surgery to address the problem.A review of complaints was performed for the previous 12 months (february 25, 2021-february 25, 2022) for device lot 400803, and no other complaint were identified for this lot.Rule in/ rule out analysis: as there are many potential causes of the implants breaking in this complaint, the rule in/ rule out strategy was used to attempt to determine the cause of the implant break.Rule out: the following potential causes of the implant break were ruled out based on the analysis performed: out of specification manufacturing, off label anatomic or fracture type use , contraindication including intramedullary canal measuring smaller than diameter of delivery sheath, open fracture with severe commination, delivery sheath unable to cross fracture site after proper fracture reduction and realignment, skeletally immature patient ,patient accident post-surgery, insufficient cortical wall contact, and insufficient quantity of bone or markedly unstable comminuted fracture.The rule in/ rule out strategy was unable to determine the root cause of the implants breaking in this complaint, as there are multiple different factors which may have contributed and it could not be determined if the root cause was due to one, or a combination of factors.The rule in/rule out strategy narrowed the potential causes to inadequate post-operative fixation, segmental fracture of radius without radial neck fracture stabilization, small diameter of cured implants, position of radius and ulna fracture midshaft, and poor reduction of fracture (bow in radius).As one root cause could not be determined, the root cause of this complaint is unknown.Rule in: the following potential contributing causes could not be ruled out, and therefore remain potential contributory causes of this event: inadequate post-operative immobilization or care instructions, such as a splint, patient over-taxing the limb prior to bone healing (e.G.Heavy lifting), segmental fracture of the radius with radial neck fracture not stabilized, small diameter of cured implants, for the diameter and type of double bone fracture being treated ,position of radius and ulna fracture at the same level to one another, and midshaft , and poor fracture reduction upon initial implantation, including angles between bone segments (bow in radius).Conclusion: the root cause of this complaint could not be determined, although many potential causes were ruled out.This is a known and documented risk of any im fixation system or rod, and this failure mode will continue to be tracked and trended.

• 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 provdience, RI 02914 ; 4107140008
• MDR Report Key: 13775228
• MDR Text Key: 291402018
• Report Number: 3006845464-2022-00001
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL07002000
• UDI-Public: M986USSL07002000
• 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: 03/14/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: USSL-0700200
• Device Catalogue Number: USSL-0700200
• Device Lot Number: 400803
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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: 83 YR