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

Catalog Number CT-0242

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.No evaluation of the device was possible as it was not able to be returned to illuminoss.A review of the manufacturing records for the devices used in this case was performed and found that the devices used were in specification at the time of manufacture and release.A review of complaints found no other complaints for these lot numbers.The firm is performing testing with devices from the same lots used in this case, to support this investigation.Followup information from the user was requested and received in support of this investigation.The patient was a cancer patient being treated for a lesion in the radius.The original treatment plan was to perform a prophylactic treatment of the lesion by placing an illuminoss intramedullary implant to span the entire length of the radius.During preparation of the bone canal, the user experienced the tip of the burr get stuck in the bone canal.Attempts to get it dislodged ultimately resulted in the burr breaking at the shaft.After multiple attempts, the user determined he was unable to remove the distal portion of the burr from the canal.The user determined to place a different, smaller illuminoss implant within the radius canal in the portion of the bone that didn't have the broken burr piece within it, and to leave the device fragment in place.The illuminoss implant treated the lesion, and the user stated he was satisfied with the clinical outcome for the patient.On (b)(6) 2023, the firm conducted an initial medical oversight review of the information provided from the user to support the investigation into the cause of the event.Follow-up requests were identified in this review, including an update on the patient's condition, and the firm has reached back out to the user for some additional information at the time of this mdr report.On (b)(6) 2023 the firm sent devices from the same lots to an external orthopedic device testing house to perform additional device evaluation testing.The firm is awaiting these testing results at the time of this mdr report.A followup mdr will be submitted when further information is known about this case.

Event Description

A patient was being treated for a lesion in the radius.During surgery to prepare the bone canal for an illuminoss intramedullary implant, a burr broke.The treating physician was unable to remove the broken piece of the instrument.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including product evaluation testing results of devices from same lot/batch the investigation findings codes investigation conclusion codes and this manufacturer's narrative with the firm's root cause conclusions.Manufacturer's evaluation no evaluation of the actual comlaint device was possible as it was not able to be returned to illuminoss.A review of the manufacturing records for the devices used in this case was performed and found that the devices used were in specification at the time of manufacture and release.A review of complaints found no other complaints for these lot numbers.Followup information from the user was requested and received in support of this investigation.The patient was a cancer patient being treated for a lesion in the radius.The original treatment plan was to perform a prophylactic treatment of the lesion by placing an illuminoss intramedullary implant to span the entire length of the radius.During preparation of the bone canal, the user experienced the tip of the burr get stuck in the bone canal.Attempts to get it dislodged ultimately resulted in the burr breaking at the shaft.The user removed the proximal piece, but the distal piece was lodged in the bone and was not able to be easily removed with the guidewire by hand.The user tried multiple methods to remove the distal piece of burr including pulling on the guidewire and using drills, guidewires, and k-wires to dislodge the burr.After multiple attempts from different angles and using different tools, the user determined he was unable to remove the distal portion of the burr from the canal.The user decided to place an illuminoss implant within the radius canal in the portion of the bone that didn't have the broken burr piece within it, and to leave the device fragment in place.After placing the illuminoss implant, the user used pliers to try pull the guidewire and burr out, and eventually pulled the guidewire through the cannulated burr with significant effort.The user reported that the ball tip was still visible on the ball tipped guidewire once removed, but the ball was deformed and reported to be "folded over" in shape.The illuminoss implant treated the lesion, and the user stated he was satisfied with the clinical outcome for the patient.In response to the firm's follow up inquiry on the patient condition on (b)(6) 2023, the user reported that the patient condition was good.The firm conducted a medical oversight review of the information and x-rays provided from the user to support the investigation into the cause of the event.Medical oversight observed that the burr is lodged flush against the bone canal.It appears from the x-rays that where the burr tip is located has narrower bone canal both before and after the burr tip.This canal anatomy (a "shoulder" of bone) around the lodged burr tip would have made it difficult for the burr to be removed.It appears as if the drill was engaged repeatedly in the same spot within the canal, which created this recess in the bone.Then the drill wouldn't have been able to move backward.Continuing to spin the burr in the same location and pulling it while stuck could have created the observed "shoulder" of bone around the burr.As the user continued to try and remove the burr by drilling as reported by the user, it may have caused the burr head to become engaged with the bone and get locked in place, so as the user continued to try and spin the drill, the burr would have become over torqued which caused the shaft to break.The cause of the cannulated burr breaking is most likely due to over torquing of the burr by the user when the burr head became engaged with the cortical bone and the user continued to power the drill.Product evaluation of devices from the same lot was performed.In-house testing was performed using devices from the same burr and guidewire lots, to attempt to simulate the failure observed in this complaint where the ball tipped guidewire was pulled through the cannulated burr.This testing included pulling the guidewire by hand, pulling with a t-handle instrument, and using a mallet.This testing was unable to replicate the reported event.Additional in-house testing was conducted for the purpose of replicating the effect of prolonged burr tip to guidewire ball friction, as might occur if the burr were lodged in a bone, and a drill used for prolonged durations to spin the burr tip while pressed against the ball of the guidewire.This testing found that under these simulated conditions, the ball of the ball-tipped guidewire can be deformed by the cannulated burr.While the guidewire was not able to be pulled through the cannulated burr in this benchtop evaluation, and the described failure mode was not able to be replicated, it is possible that with enough time, under the conditions tested above where the ball of the guidewire is pulled against the tip of a burr while spinning, the ball tip could be deformed enough to pull through the cannulated burr by using a power drill.The firm sent devices from the same lots to an external orthopedic device testing house to perform additional device evaluation testing.The tensile load required to pull a ball tipped guidewire through a cannulated burr was evaluated by rihof.The average maximum tensile load was 1057 n with a standard deviation of 72n, and minimum result of 974n, which exceeds the minimum tensile failure strength requirement for the ball tip to guidewire connection of 356n per the device design specification.Additionally, the minimum value observed (974n) is more than 6 times greater than the average pull-strength of standing men, (148n).The observed failure mode for all 3 samples was ball tip deformation.This testing demonstrates that the load required to pull the ball tipped guidewire through the cannulated burr for 3 samples within the lots involved in this complaint exceeds the pull strength ability of men, and also exceeds the strength requirement of the ball tip to guidewire connection design specification.As the guidewire is intended to be pulled by hand or by t-handle in order to remove it, the specification for strength for this instrument is appropriate, and the specific representative devices from the same lot were found to have exceeded this specification.Conclusion the cause of the cannulated burr breaking is most likely due to over torquing of the burr by the user when the burr head became engaged with the cortical bone and the user continued to power the drill.The cause of the distal broken portion of broken burr being unable to be removed by the ball tipped guidewire is likely due to the canal anatomy created around the lodged burr tip, which prevented removal of the burr head by pulling on the guidewire by hand or t-handle.

• 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: 16162785
• MDR Text Key: 307464606
• Report Number: 3006845464-2023-00002
• 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,Followup
• Report Date: 03/06/2023

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 Catalogue Number: CT-0242
• Device Lot Number: 400515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GUIDEWIRES CT-0243-01 LOTS 420491, 420761, 411009
• Patient Outcome(s): Other
• Patient Sex: Male