MAUDE Adverse Event Report: ORBIT BIOMEDICAL, INC. ORBIT SUBRETINAL DELIVERY SYSTEM

Model Number	PN1007128C
Medical Device Problem Codes	Defective Component (2292); Dull, Blunt (2407)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The orbit sds was returned to orbit biomedical and subjected to preliminary testing consisting of visual microscopic inspection, dimensional analysis, functional testing, and review of surgical video.The initial findings suggest that the tip of the needle was bent, but there was no burr present.The internal investigation results have been sent to the contract manufacturer for further analysis and these findings will be provided in a follow-up report.Review of the surgical video revealed the bent tip was present before the device entered the eye.Manufacturer reference #: (b)(4).
Event or Problem Description
The orbit subretinal delivery system (sds) with the curved needle configuration was used on (b)(6) 2020 for delivery of an investigational cell therapy under an approved ind study.During the procedure the sds was unable to pass through the choroid to access the subretinal space.After 30 minutes of attempting to access the subretinal space to create the entry bleb, the cell viability window had expired; therefore, the needle of the injection cannula was retracted and the device was removed from the patient.Upon examination, the retina specialist reported observing a defect at the distal tip of the needle which he described as a burr; post-surgery images confirmed presence of a bend at the distal needle tip.A second orbit sds device was used to successfully create the entry bleb and the procedure was completed without incident.The event did not result in any adverse impact to the patient, who was reported to be healing nicely.
Additional Manufacturer Narrative
The orbit sds was sent to the contract manufacturer for evaluation.The device was examined microscopically and damage described as a 'hook' defect was confirmed at the tip of the distal needle.While the investigation could not identify a definitive root cause for the needle damage, two suspected causes were identified.The first possible cause is failure to detect damage during the manufacturing, assembly, and/or final inspection process (manufacturing defect); the second possible cause is damage sustained during preparation for use (use error) that was undetected prior to entering the eye.Manufacturer reference #: (b)(4).

• Brand Name: ORBIT SUBRETINAL DELIVERY SYSTEM
• Common Device Name: SUBRETINAL DELIVERY SYSTEM
• Manufacturer (Section D): ORBIT BIOMEDICAL, INC.; 300 brookside ave; building 18, suite 180; ambler PA 19002
• MDR Report Key: 10279867
• Report Number: 3015259839-2020-00001
• Device Sequence Number: 667287
• Product Code: FMF
• UDI-Device Identifier: 00860000540513
• UDI-Public: 00860000540513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: PN1007128C
• Device Lot Number: B19MAR004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPREGEN (CELL CURE NEUROSCIENCES)
• Patient Age: 74 YR