MAUDE Adverse Event Report: SYNERGETICS 20GA ONE-STEP¿ SUTURELESS CANNULA; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number 58.20-6

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that a one-step sutureless cannula failed during surgery.When the surgeon attempted to remove the trocar at the end of the procedure, the top of the trocar broke off leaving the cannula in the eye.The surgeon had to go back into the eye and retrieve the cannula part of the trocar that fell down onto the retina.A 20ga incision was made to enlarge the incision using a v-lance blade.After several attempts of trying to retrieve the cannula with different types of forceps, the surgeon decided to use a chandelier light fiber so that two forceps could be used to grasp the cannula.The cannula was then removed from the back of the eye.Incision was enlarged, but no sutures were required.

Manufacturer Narrative

The product was returned but not evaluated yet.This investigation is ongoing.

Manufacturer Narrative

The cannula was returned in an alcon product tray inside a synergetics product pouch for a 58.20-6 one-step sutereless cannula.This cannula was manufactured by an external supplier.The polyimide tube that gets bonded to the abs hub is in two pieces, one loose in the tray, one still bonded to the hub.The break in the tubing is irregular and jagged, with splits or cracks evident.Part of the tubing still attached to hub appears to be rolled inward suggesting the tube bent or folded prior to breaking.The device history review did not reveal any negative quality patterns and there were no associated non-conformances.The vendor reported inspection for through hole diameter (to ensure no resistance with 20ga instruments inserted) and for polyimide/cannula bond strength, this defect would have been detected prior to packaging.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: 20GA ONE-STEP¿ SUTURELESS CANNULA
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SYNERGETICS; 3845 corporate centre dr.; o''fallon MO 63368
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o''fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17969750
• MDR Text Key: 326136872
• Report Number: 0001932402-2023-70006
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 20841305108176
• UDI-Public: (01)20841305108176(17)251117(10)M0045868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58.20-6
• Device Lot Number: M0045868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• 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
• Treatment: 23GA ALCON VITRECTOMY PACK