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

Model Number	SP-683G
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, in a surgical excision, when the surgeon went to gently wipe the area with alcohol, the knot unraveled and the suture broke apart in the middle of the site.Another suture from a different box was used but the same issue occurred.
Additional Manufacturer Narrative
D10 concomitant product: sp-683g, sp-683g surgipro* 4-0 blu 45cm c13 x12 (lot#unknown) 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
• 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: 25577599
• Report Number: 9612501-2026-01689
• Device Sequence Number: 9020578
• Product Code: GAW
• UDI-Device Identifier: 10884521037472
• UDI-Public: (01)10884521037472(17)290930(10)D4K4428FGY(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K954808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: SP-683G
• Device Catalogue Number: SP-683G
• Device Lot Number: D4K4428FGY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 10/30/2024
• 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
• Patient Sex: Unknown