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

Catalog Number SY-2000-01

Device Problem Defective Device (2588)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

An illuminoss distributor reported that during a routine check of an illuminoss photodynamic curing system (a.K.A.Light box), she noticed the light seemed dimmer than expected.This potential device defect was identified without user or patient involvement.

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The firm has conducted a review of the manufacturing records for the device, and found that the device met specifications at the time of manufacture and release.The firm has conducted follow-up interviews with the distributor who identified the product problem.On january 25, 2023 the firm received the returned device from the distributor.The firm is performing device evaluation in order to complete the complaint investigation.A follow up mdr will be submitted when further information is known about this case.

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, device component code, the investigation findings codes, investigation conclusion codes, and this manufacturer's narrative with the firm's root cause conclusions.The firm has conducted a review of the manufacturing records for the device.This device is the photodynamic light curing system, and the manufacturing testing records for light output both of the light box, as well as the unit's light guide component were reviewed and found that the device and all components met specification for light output at the time of manufacture and release.The firm received the returned device from the distributor, and performed returned product evaluation.Through this activity, the cause of the dim light emission was identified as the optical taper portion of the light guide component of photodynamic light curing system, and not the light box itself.The light box itself, and the portion of the light guide when swapped with a different optical taper, emitted light within specification.Further evaluation of the optical taper end of the light guide identified damage internal to this component, broken light fibers.The review of manufacturing records identified that this component (the light guide paired with this same optical taper) emitted light within specification at the time of device manufacture and release.The observed damage to the optical taper is therefore likely to have been sustained during user handling or transport between cases.The cause of the damage to the optical taper portion of the light guide component of the photodynamic light curing system could not be definitively determined.Of the known causes of this failure mode, the cause that could not be ruled out with the objective evidence available is light guide damage from improper handling.The ifu 900368 for the illuminoss photodynamic light source includes instructions to "handle the light guide with care, as sharp bends will reduce light output and cause permanent damage." the cause of the reported "dim" light output from this photodynamic light curing system is due to the light guide not transmitting a sufficient amount of light from the light box to the distal end of the light guide.The cause of the reduced light output through the light guide is damage to the glass fibers observed within the optical taper.Improper handling of the device is a probable cause of the damage, which led to the out of specification light emission from this device, although this cannot be proven with the information available to the firm.

• 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: 16402881
• MDR Text Key: 310137276
• Report Number: 3006845464-2023-00005
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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: Other
• Device Catalogue Number: SY-2000-01
• Device Lot Number: 400508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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