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

Model Number	SC-643
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, in wound closure, the thread came loose from the needle several times.Additionally, on the third device, the thread broke in half during suturing.The needle did not fall into the patient's cavity.An additional new suture was used without issue.
Additional Manufacturer Narrative
D10.Concomitant products: sc-643, sc-643 caprosyn* 3-0 und 75cm sc2 x36 (lot d4a3964y); sc-643, sc-643 caprosyn* 3-0 und 75cm sc2 x36 (lot d4a3964y).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.One opened and fifty-eight opened devices were available for evaluation.Visual inspection of the opened sample showed one suture returned without a needle, broken into three segments with no damage observed on the foil pouch.Representative samples showed intact breathable pouches, properly parked needles, correctly wound sutures, and no abnormalities upon tactile or microscopic inspection, with foil pouches also free of defects.Tensile testing could not be performed on the opened sample due to potential degradation after opening.For representative samples, breathable pouches were opened cleanly, sutures were removed easily, and no breakage or fraying occurred during loading onto the instron machine.The sutures were pulled at 300¿mm/min until needle detachment, with load forces meeting the mean and individual specifications; however, further testing was halted after two samples showed notably lower results.It was reported that the thread came loose from the needle several times and the thread broke in half during suturing.The reported issue was 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.The instructions included with this device provide the following guidance: progressive loss of tensile strength and eventual absorption of the absorbable sutures occurs by means of hydrolysis.This loss is triggered when exposed to the environment or clinical application.Damage during use may result in inadequate sample length to perform testing and/or deformation of the suture contributing to a loss in tensile strength.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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23342161
• Report Number: 9612501-2025-02741
• Device Sequence Number: 20822539
• Product Code: GAM
• UDI-Device Identifier: 10884521034969
• UDI-Public: (01)10884521034969(17)261231(10)D4A3964Y
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 02/10/2026

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: SC-643
• Device Catalogue Number: SC-643
• Device Lot Number: D4A3964Y
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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