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

Catalog Number ML-009160

Device Problem Gas/Air Leak (2946)

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

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The user reported no unusual handling or deviation from the manufacturer's instructions for use when preparing the device prior to the procedure.The product was able to be returned to the firm for device evaluation.The firm received the device at its device decontamination site on june 1, 2023, and device decontamination was initiated on june 8 2023.A review of the manufacturing records for the device used in this case was performed and found that the device met its final release specifications at the time of manufacture and release.A review of complaints found no other complaints for this lot number.Product evaluation is in process of being performed at this time, and a followup mdr will be submitted when further information is known about this case.

Event Description

An 87 year-old female was being treated for a traumatic fracture in germany, using an illuminoss implant [size 9x160mm].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 device was not used.The user used another illuminoss implant, and the operation went smoothly.

Manufacturer Narrative

At the time of this followup 1 mdr report, the investigation into the cause of the event is still ongoing.This followup mdr is to submit an update on the progress of the on-going product evaluation activities the firm is performing.The firm received the returned device from germany at its decontamination service provider on(b)(6) 2023.The firm received a photo-imaging documentation report from its decontamination service provider on (b)(6) 2023.The device is currently being shipped to the manufacturer, in order to perform further device testing and evaluation.A follow up mdr will be submitted when firm completes the device evaluation activities in progress.

Manufacturer Narrative

At the time of the previous 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 results of returned complaint device - the investigation findings codes - investigation conclusion codes - and this manufacturer's narrative with the firm's root cause conclusions.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 confirmed the implant has a leak.Further in-house testing was able to eliminate multiple potential sources of the leak, but was unable to identify the exact location of the leak, and therefore cause of the leak.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 exact 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: 17101423
• MDR Text Key: 317751733
• Report Number: 3006845464-2023-00035
• 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,Followup,Followup
• Report Date: 08/02/2023

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: Health Professional
• Device Catalogue Number: ML-009160
• Device Lot Number: 420654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 05/12/2023; 05/12/2023
• Supplement Dates FDA Received: 07/05/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 51 KG