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

Model Number	8886613431-2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant medical product: 8886613431-2 maxon 4-0 36 grn cv-23 da 8886613431-2 (lot d4c3759y) 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 laparotomy procedure, two maxon 4-0 sutures broke while suturing.The surgeon used another suture to c omplete the procedure without further issues.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted from photo that there was two sutures and one needle.The needle was disengaged from the one of suture.The visual inspection of the returned product noted one partial suture and one needle.The suture segment measured 5 11/16 inches.The measurement was taken with a steel rule, calibrated asset 28697.The suture did not exhibit any of the characteristics of degradation.Upon microscopic inspection of the needle, normal crimp and swage marks were noted.Tool marks were observed on the needle swage.The needle swage was observed to be full of suture material.The foil pouch was inspected with light assisted microscopy with no abnormalities.Functional testing found that as the product was returned open and no sealed samples were returned, a tensile strength test could not be performed.The tensile strength of absorbable sutures may be affected by degradation of the suture and/or damage durin g use after the product has been opened and may impact the validity of any test results.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.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: MAXON
• 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: 21087238
• Report Number: 9612501-2025-00080
• Device Sequence Number: 6898812
• Product Code: GAM
• UDI-Device Identifier: 10884521757783
• UDI-Public: 10884521757783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K990951
• 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): 04/01/2025

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: 8886613431-2
• Device Catalogue Number: 8886613431-2
• Device Lot Number: D4C3759Y
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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