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

Model Number	8886620721
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 8886620721, 8886 6207-21 maxon 5-0 grn 75cm cv23x36, (lot#d0m2037y).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
According to the reporter, during an ileostomy repositioning procedure, after opening the packaging, the suture was used and the needle had come off the thread.The issue occurred on 11 sutures.Another suture package was opened and used to resolve the issue.There was no patient injury.
Event or Problem Description
According to the reporter, during ileostomy repositioning procedure, after opening the packaging, the suture was used, and the needle had come off the thread, which happened twice.Another suture package was opened and used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
H6 additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.Nine representative samples were returned for analysis.No information regarding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that the needle was detached.Visual inspection noted that a tactile and microscopic inspection of the first three sutures was performed with no observed abnormalities.The fourth sample's needle was detached from the suture while attempting to remove the suture from the retainer.Upon microscopic inspection deformation of the swage hole was observed.The foil pouches were inspected with light assisted microscopy with no abnormalities.A tensile test was performed on three sealed samples and the results for these samples met the specifications for this product.Due to the needle of the fourth sample detached from the suture during removal, additional functional testing was precluded.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.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: 19690926
• Report Number: 9612501-2024-01668
• Device Sequence Number: 7117922
• Product Code: GAM
• UDI-Device Identifier: 10884523002263
• UDI-Public: 10884523002263
• 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,Followup
• Report Date (Section B): 11/19/2024

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 Expiration Date: 11/30/2025
• Device Model Number: 8886620721
• Device Catalogue Number: 8886620721
• Device Lot Number: D0M2037Y
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 11/06/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/28/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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