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

Catalog Number ML-09120

Device Problem Gas/Air Leak (2946)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During routine device preparation, when following the manufacturer's instructions to check that the balloon can hold a vacuum by drawing out the air with a syringe, the user found that the device could not hold a vacuum.The user took the implant out of the packaging.With the first syringe, a vacuum could not be built up.The user then tried with the 2nd syringe and no vacuum was possible either.The user did not use the device.A replacement device was used.The surgery then went smoothly without significant delay.As this malfunction may cause or contribute to serious injury, this event is being submitted as a malfunction mdr.

Manufacturer Narrative

Returned product evaluation: the returned product was evaluated by illuminoss engineering staff.A vacuum was attempted to be established and it could not be, which confirms the implant has a leak.The location of the leak was attempted to be located by filling the implant with air and submerging under water, and bubbles were observed coming out from the first vent hole in the y-connector.The presence of air bubbles coming from the first vent hole indicate the leak is in the guide tube and could be present at either of the guide tube bond joints or the length of the tube.The leak location was attempted to be further identified using dye, but the exact bond or location of the leak could not be determined.Dhr review: the manufacturing records for the device were reviewed, and found that the device met specification at the time of manufacture and release.Special attention was paid to the manufacturing steps involving leak testing, and all units in this lot passed, indicating there was no leak at the time of manufacture release.Special attention was also paid to the flow tube and guide tube components based on the returned product evaluation, and these components were also found to be in specification at the time of manufacture release.Complaint review: complaints in the previous 12 months (june 28, 2021-june 28, 2022) were reviewed for if lot: 420407 was involved in other complaints and no other complaints were identified.Review of ifu and potential for user error: there is no indication that user error contributed to this complaint.The distributor stated the implant was handled with care, did not experience any rough handling or damage, and the scrub nurse followed the correct steps for implant preparation.In addition, the user did not use the implant which was unable to establish a vacuum, per the instructions for use.The manufacturer's instructions for use instruct the user to perform this preparation step, and then to not use the balloon if it cannot draw a vacuum.In the surgical technique guide the user is instructed "note: if a vacuum cannot be achieved with a specific implant, it may have been compromised in some fashion.Do not use an implant that will not hold a vacuum.Discard that implant and replace it with a new sterile implant." risk review: the failure mode of not being able to draw a vacuum during device prep can lead to a device leak if used.This failure mode can lead to the doctor needing to remove a leaking balloon and replace it with another balloon, or use an alternative fixation method.Conclusion: the device was in specification at the time of manufacture and release, there is no indication of user error contributing to the failure, and the location of the leak could not be identified in the returned product evaluation.The cause of the implant being unable to draw a vacuum was unable to be determined, and therefore the cause is unknown.

• 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: 15911709
• MDR Text Key: 308031945
• Report Number: 3006845464-2022-00020
• 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
• Report Date: 12/02/2022

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: Health Professional
• Device Catalogue Number: ML-09120
• Device Lot Number: 420407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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