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

Model Number	VP-745-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a peripheral side anastomosis in vascular bypass surgery, the suture was damaged.The same issue occurred on the other two sutures.Surgical time was extended by a few minutes.A new product of the same lot number was unpacked and used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: vp-745-x surgiproii 8-0 60cm mv1758da - (lot#d2l2994y); vp-745-x surgiproii 8-0 60cm mv1758da - (lot#d2l2994y) 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.The device was available for evaluation.Visual inspection noted that the returned product had six needles and five sutures.Five needles were returned attached to their sutures.The five sutures were returned broken.The length of suture a measured 12 1/8 inches from the needle attachment point.The length of suture b measured 5 1/8 inches from the needle attachment point.The length of suture c measured 8 11/16 inches from the needle attachment point.The length of suture d measured 12 3/8 inches from the needle attachment point.The length of suture e measured 12 3/8 inches from the needle attachment point.The measurement was taken with an aluminum rule, calibrated asset nh02505.Needle f was returned detached from its suture.Upon microscopic inspection, the needle swage was noted to be full of suture material, indicating suture breakage at the swage.Visual examination of the representative samples notes that the light-assisted microscopic inspection of the breathable pouch noted no breaches or damage.The needles were properly parked in the retainer.Inspection of the retainer noted the suture was properly wound and no damage to the retainer.A tactile and microscopic inspection of the sutures was performed with no abnormalities.Functional testing found on the representative samples 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 (asset # 35526) by clamping the ends with cord yarn grips.No suture breaking or fraying was noted while handling/loading the suture into the instron machine.The instron then pulled the suture at a rate of 300 mm/min until the suture broke.The breaking point load force was measured and found to meet usp minimum mean and minimum individual specifications.It was reported that the suture was broken.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21577033
• Report Number: 9612501-2025-00718
• Device Sequence Number: 8431335
• Product Code: GAW
• UDI-Device Identifier: 10884521038905
• UDI-Public: 10884521038905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050947
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: VP-745-X
• Device Catalogue Number: VP-745-X
• Device Lot Number: D2L2994Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sex: Unknown