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

Model Number	SC-543
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot#d3j3125y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot# d3j3125y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot# d3j3125y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot# d3j3125y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot#d3j3125y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot# d3j3125y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot# d4a3772y); sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot# d3j3125y).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 c-section surgery, the six sutures strand broke in the middle when tension was applied to tighten the knot.The issue was resolved by using another suture from a different lot number.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.Three opened and one hundred and forty-eight representative samples were returned for analysis.Visual inspection of the opened samples noted three needles and three sutures.The needles were returned attached to the sutures.Two of the sutures were returned broken.Suture a broke 27 1/2 inches from the needle attachment point.Suture b broke 2 7/8 inches from the needle attachment point.The foil pouches were inspected and identified no signs of damage or abnormalities.Visual inspection of the representative samples noted light assisted microscopic inspection of the breathable pouches noted no breaches or damage.The needle was 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.The foil pouch was inspected and identified no signs of damage or abnormalities.Functionally, tensile strength test could not be performed on the opened samples.The tensile strength of absorbable sutures may be affected by degradation of the suture and/or damage during use after the product has been opened and may impact the validity of any test results.On the representative samples, the breathable pouch was opened without any tears of the tyvek packaging.The suture was removed from the retainers without any dif ficulty.A simple knot was performed on the suture and the knot was pulled tight.The suture ends were loaded onto an instron machine 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 sutures broke.The breaking point load force was measured and did not meet ep minimum mean specifications.It was reported that the suture broke.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: 22665611
• Report Number: 9612501-2025-02076
• Device Sequence Number: 3716595
• Product Code: GAM
• UDI-Device Identifier: 10884521034709
• UDI-Public: (01)10884521034709(17)260831(10)D3J3125Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 10/14/2025

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-543
• Device Catalogue Number: SC-543
• Device Lot Number: D3J3125Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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
• Patient Sex: Unknown