MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CAPROSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	SC-5780G
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sc-5780g caprosyn* 3-0 und 75cm p14x12 - sc-5780g, lot# d3h1795fy sc-5780g caprosyn* 3-0 und 75cm p14x12 - sc-5780g, lot# d3j3552fy sc-5780g caprosyn* 3-0 und 75cm p14x12 - sc-5780g, lot# d3h1795fy.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 surgical procedure involving the suture, there were issues with needle detachment and suture breakage.The needle detached while suturing and preparing the suture after the patient incision, and the suture broke at the connection of the needle and thread during suturing.The needle did not fall into the patient cavity.Multiple defective devices from the same product id and lot number were involved in the same event with the same patient.Initially, an additional new suture was used without issue, but the same problem occurred, leading to the use of another manufacturer's product.There was no consequence or impact to the patient, and the patient remained alive with no injury.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: b5, g3.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 plastic surgery involving the suture, there were issues with needle detachment and suture breakage.The needle detached while suturing and preparing the suture after the patient incision, and the suture broke at the connection of the needle and thread during suturing.The needle did not fall into the patient cavity.Multiple defective devices from the same product id and lot number were involved in the same event with the same patient.Initially, an additional new suture was used without issue, but the same problem occurred, leading to the use of another manufacturer's product.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Two opened and eighteen sealed representative samples were returned for evaluation.Visual inspection of the opened samples noted the needles with suture material in the swage.The sutures were returned degraded and broken into small fragments.It was reported that there was needle detachment and suture breakage.The reported issues were confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: CAPROSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• 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: 21865708
• Report Number: 9612501-2025-01086
• Device Sequence Number: 4721626
• Product Code: GAM
• UDI-Device Identifier: 10884521034921
• UDI-Public: 10884521034921
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032586
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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: SC-5780G
• Device Catalogue Number: SC-5780G
• Device Lot Number: D3J3552FY
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 08/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/08/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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.
• Patient Sex: Unknown