MAUDE Adverse Event Report: SYNERGETICS STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER; INSTRUMENT, MICROSURGICAL

Model Number	20.04.25S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was received for evaluation open in its original pouch.The tip protector was on the end of the handle.The tube and internal carbide rod that make up the shaft had broken off approximately 2mm from the handle and was taped to a yellow piece of paper.The tube at the point of the break appeared stretched and torn.The carbide is cleanly broken.The probe appears to have been exposed to radial stresses that exceeded the strength of the shaft.Information supplied by user confirmed, device was used with a valved cannula.Instructions for use warnings state, only retractable ddms products are compatible with valved cannulas.Manufacturing and sterilization records were reviewed and found to be acceptable.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.
Event or Problem Description
It was reported that the tip of the diamond dusted membrane scraper broke off at the hub into the back of the patient''s eye and injured the retina (after it broke off of handle) causing microscopic tearing.The surgeon removed the tip from the eye, and lasered the back of the eye where the diamond dusted tip hit.The surgery was prolonged an additional three minutes.The patient is doing well after surgery.

• Brand Name: STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER
• Common Device Name: INSTRUMENT, MICROSURGICAL
• 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: 17400442
• Report Number: 0001932402-2023-70003
• Device Sequence Number: 15368118
• Product Code: GZX
• UDI-Device Identifier: 20841305108848
• UDI-Public: (01)20841305108848(17)250614(10)M0043153
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2025
• Device Model Number: 20.04.25S
• Device Lot Number: M0043153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND ACCESSORIES
• Patient Sex: Unknown