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

Catalog Number USSL-2213260

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/11/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, an illuminoss implant (size ussl-2213260) was used to treat a patient with a traumatic mid shaft humeral fracture.The implant was removed on (b)(6) 2022 due to implant break distal to the fracture site and orif with a plate was performed.The patient condition following the revision surgery is reported as good.Although the investigation is still ongoing into the cause of the implant break, this incident necessitated surgical intervention to add additional fixation (orif and plate) to achieve stabilization of the original bone fracture, and therefore this initial mdr is being submitted.

Manufacturer Narrative

The investigation into the root cause of this event is underway.Follow up with user: we have attempted to reach out to the doctor multiple times for followup questions, and will continue to do so.Returned product evaluation: product was not returned.Device was disposed of in the operating room.Dhr review: a review of the manufacturing records associated with this device was performed.The device met specification at the time of manufacture and release.Review of ifu: ifu 900365 rev.W was reviewed.The risk of possible implant break is included in the labeling, "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" product images: pictures of the explanted device were provided by the user.X-rays: radiographs of the treated anatomy were requested and received from the user.Medical oversight review: additional review of the information about the case, product images, and x-rays was performed with medical oversight, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and came the following conclusions with the information we have so far: the user reported there were no known extreme forces or traumatic event that may have caused the implant to break.The fracture that was treated involved a large comminuted fragment.The implant broke at the narrowest portion over the fracture, and the explant is very thin at the break point.The implant was not in full contact with the cortical wall for the full length of the implant.Medical oversight is still investigating this incident, including contacting the user for additional followup information regarding the incident and the procedure.A supplemental mdr will be submitted.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation was still underway.This followup mdr is submitted to submit new information, including the investigation findings codes.Investigation conclusion codes.And this manufacturer's narrative with the firm's root cause conclusions.Product images and x-rays: pictures of the explanted device were provided by the distributor.It was noted by the distributor that the implant broke at the very narrow portion of the implant.Medical oversight review.Additional review of the information about the case, product images, and x-rays was performed with medical oversight, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and made the following observations: the user reported there were no known extreme forces or traumatic event that may have caused the implant to break.The fracture that was treated involved a large comminuted fragment the implant broke at the narrowest portion over the fracture, and the explant is very thin at the break point.· the implant was not in full contact with the cortical wall for the full length of the implant.As a result of this medical oversight review, additional information was requested from the user, however the firm has not received a response after multiple attempts.Investigation findings: it was observed that this was a highly comminuted fracture, and it is possible that the comminution was not identified at the time of the illuminoss implantation.It was also observed in the immediate post op x-rays that the implant is very thin over a portion of the fracture, which was the location of the implant break.Further it was observed that the explanted implant was very thin at the location of the break.The implant width in the immediate post op x-ray was found to be about 9mm at the thinnest part of the implant where the break occurred.It was observed that the implant was filled in the proximal and distal portions of the bone canal with sufficient cortical wall contact, but the middle portion over the fracture was very thin with no cortical wall contact.The use of the illuminoss implant in this way in this anatomy - without cortical wall contact, and with a dramatic narrowing point of the implant at the location of the fracture - was identified as the cause of the implant break.The cause of the user placing the illuminoss implant in this way so as to generate significantly thinner portion at the fracture site remains unknown, although the firm has reached out to the user with followup questions to attempt to identify the potential cause.Surgical technique guide 900510_d includes the information that fracture stabilization cannot be assured when the illuminoss implant is not in contact with the cortical wall.This technique guide also notes that a minimum canal diameter of 13mm is required for the stand-alone use of the implant in load bearing indications, and instructs the user to utilize fda cleared plates in conjunction with the implant in those cases where the implant will not achieve 13mm in diameter in the area of the fracture.In this case, the implant was not able to achieve 13mm in diameter in the area of the fracture, nor was cortical wall contact observed with the implant at the narrowest portion of the implant, across the fracture site.The user's use of the illuminoss implant in this way, with a significant narrowing of the implant at the point of the fracture site, and without cortical wall contact there at the fracture site, are the cause for the implant break, as a result of use error.

• 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: 15784921
• MDR Text Key: 303558991
• Report Number: 3006845464-2022-00010
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

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 Catalogue Number: USSL-2213260
• Device Lot Number: 411150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White