MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number	VP556X-2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coronary artery bypass grafting procedure, while suturing, the suture broke.It occurred on two sutures.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant product: vp556x-2, srgproii 5-0 36 bl cv-23 da vp556x-2 (lot#d1b0555y).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
It was reported that during a coronary artery bypass graft (cabg) procedure, while suturing, the suture broke.It occurred on two sutures.A product of another manufacturer was used to resolve the issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: b5, e1 (facility name), g3, h6 (imf).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: d9, g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.Thirty-five representative samples were available for eval uation.Visual inspection of the representative samples noted that the breathable pouches showed no breaches or damage, and the needles were properly parked in the retainers.Inspection of the retainers confirmed that the sutures were properly wound with no damage to the retainer.A tactile and microscopic inspection of the sutures was performed, and no abnormalities were observed.The foil pouches were also inspected, and no signs of damage or abnormalities were identified.Functional testing noted that the breathable pouches were opened without any tears in the tyvek packaging, and the sutures were removed from the retainers without difficulty.A simple knot was performed on each suture, and the knot was pulled tight.The suture ends were then loaded onto an instron machine by clamping the ends with cord yarn grips.No suture breaking or fraying was observed during handling or loading.The instron pulled the sutures until they broke, and the breaking point load forces were measured and found to meet ep minimum mean and minimum individual specifications.A total of fifteen sealed samples were split in half, and each half was functionally tested for a total of thirty t est samples.According to the ep procedure for simple knot testing, sutures longer than 75 mm were submitted for two measurements, and shorter sutures for one measurement.Based on the results of the simple knot test, the representative samples were deemed satisfactory.It was reported that the suture broke.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: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• 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: 23704318
• Report Number: 9612501-2025-03226
• Device Sequence Number: 18814247
• Product Code: GAW
• UDI-Device Identifier: 10884521758582
• UDI-Public: (01)10884521758582(17)260131(10)D1B0555Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K010909
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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 Expiration Date: 01/31/2026
• Device Model Number: VP556X-2
• Device Catalogue Number: VP556X-2
• Device Lot Number: D1B0555Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 03/19/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/10/2025; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown