MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	N-2770-K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Breakdown (2681); No Clinical Signs, Symptoms or Conditions (4582); Eye Irritation (4803)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a pterygium excision and limbal stem cell transplantation in the left eye, when the 10-0 suture was used to suture the conjunctival graft patch, the suture had thread breakage frequently.This results in increased surgical time of less than 10 minutes.It was noted that there was no alternative suture, continued to use the current suture.There was no patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, g3, h1, h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a pterygium excision and limbal stem cell transplantation in the left eye, when the 10-0 suture was used to suture the conjunctival graft patch, the suture had thread breakage frequently.This results in increased surgical time of less than 10 minutes.It was noted that there was no alternative suture, continued to use the current suture.Immediately after the procedure, it was noted that too many knots caused discomfort in the patient's eye after the surgery.To resolve the issue, the surgeon re-operated and used a new suture.

• Brand Name: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21602744
• Report Number: 9612501-2025-00760
• Device Sequence Number: 14546209
• Product Code: GAR
• UDI-Device Identifier: 10884521076396
• UDI-Public: 10884521076396
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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 Model Number: N-2770-K
• Device Catalogue Number: N-2770-K
• Device Lot Number: D4F4351Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 06/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female