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

Model Number	SN-3697
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d2909fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d2909fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d2909fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d2909fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy); sn: (b)(6) monosof* 6-0 blk 45cm p10 x12 - (lot#: d4d3259fy).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 procedure, the thread of 15 sutures broke in the middle, while other 9 sutures from different batch had the same issue.A new suture from a different batch was used to complete the case.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.One opened device with the appropriate packaging and eleven representative sealed samples were available for evaluation.Visual inspection of the opened sample revealed two sutures and two needles.One opened breather pouch and an empty suture retainer were also returned.The needles remained attached to their sutures, which were broken.Suture "a" and suture "b" were broken from the needle attachment point.The measurements were taken with an aluminum rule.Inspection of the pouch showed no damage or breaches.The needles were properly parked in the retainer, and the sutures were properly wound with no damage to the retainer.A tactile and microscopic inspection of the sutures was performed with no abnormalities.Functional testing noted that the breathable pouch was opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.A simple knot was performed on the suture and the knot was pulled tight.The suture ends were loaded onto an instron machine by clamping the ends with cord yarn grips.No suture breaking or fraying was noted while hand ling or loading the suture into the instron machine.The instron then pulled the suture until the suture broke.The breaking point load force was measured and were found to meet specifications.Based on the results of the simple knot test, the representative samples tested satisfactory.It was reported that the sutures broke in the middle.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.

• 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: 23892244
• Report Number: 9612501-2025-03453
• Device Sequence Number: 11917033
• Product Code: GAR
• UDI-Device Identifier: 10884521078048
• UDI-Public: (01)10884521078048(17)290331(10)D4D3259FY
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Model Number: SN-3697
• Device Catalogue Number: SN-3697
• Device Lot Number: D4D3259FY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown