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

Model Number	N-2770-K
Medical Device Problem Codes	Product Quality Problem (1506); Unraveled Material (1664)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: n-2770-k n-2770-k monosof* 10-0 blk 30cm se1406da - (lot#d3g3458y); n-2770-k n-2770-k monosof* 10-0 blk 30cm se1406da - (lot#d3g3458y); n-2770-k n-2770-k monosof* 10-0 blk 30cm se1406da - (lot#d4h3163y); n-2770-k n-2770-k monosof* 10-0 blk 30cm se1406da - (lot#d4h3163y); 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, one day after a laparoscopic vitrectomy, the five sutures ruptured.The patient was subsequently readmitted to the hospital for ambulatory care and had an additional surgery with a use of a new suture from a different brand.The physician reported that the color of the sutures was differed from the labeling on the box.The packaging indicated that the sutures were black; however, before use, some sutures were gold colored.

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25759556
• Report Number: 9612501-2026-01847
• Device Sequence Number: 13379848
• Product Code: GAR
• UDI-Device Identifier: 10884521076396
• UDI-Public: (01)10884521076396(17)280630(10)D3G3458Y(20)01
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: D3G3458Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 07/31/2023
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female