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

Model Number	UL-877
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, in a laparoscopic procedure, when closing the trocar incision, the needle and thread broke in a single pull.Three sutures had the issue.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: ul-877, ul-877 polysorb* 0 vio 75cm gu46 x36, (lot # d4a3734y); ul-877, ul-877 polysorb* 0 vio 75cm gu46 x36, (lot # d4a3734y); ul-877, ul-877 polysorb* 0 vio 75cm gu46 x36, (lot # d4a3734y).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.One opened and thirty-two representative devices were avai lable for evaluation.Visual inspection of the opened sample noted one suture and one needle.The needle was returned attached to the suture.The suture was broken at the swage.Visual inspection of the representative samples noted no abnormalities.Functional testing found that the load force at the point of detachment was measured and the results were found to meet the mean and individual specifications for this product.Following testing, the fifth sample was noted to have broken from 70 pounds per square inch of compression.It was reported that the needle and thread broke in a single pull.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.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: POLYSORB
• 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: 24341409
• Report Number: 9612501-2026-00374
• Device Sequence Number: 9927465
• Product Code: GAM
• UDI-Device Identifier: 10884521049628
• UDI-Public: (01)10884521049628(17)281231(10)D4A3734Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• 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): 04/24/2026

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: UL-877
• Device Catalogue Number: UL-877
• Device Lot Number: D4A3734Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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