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

Model Number	GLJ-50-M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, after the colon was reconstructed by functional in a colectomy, suture was used for reinforcement.When the needle tip was grasped with the needle holder and the suture was pulled out, the needle flew off.No device component fell into the patient¿s cavity.The needle was tip was damaged.The needle tip remained in the needle holder.The needle that flew off was collected.There was no patient injury.
Additional Manufacturer Narrative
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.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.The device and five sealed representative samples were ava ilable for evaluation.The visual inspection of the opened sample noted five needles and one suture.Four needles were received parked within the retainer foam.The suture was received attached to a needle and fully wound within the retainer.One needle was received broken at the tip.Upon microscopic inspection, instrument marks were observed near the break site.Visual inspection of the breathable pouches and foil pouches indicated no breaches or abnormalities.The sutures were observed to be properly wound within the retainer.A tactile and microscopic inspection of the sutures was performed.No difficulty was experienced removing the sutures from the retainer.The wire diameter of the needles was verified with a calibrated digital caliper.A bend moment test was performed on the sealed samples and test results met the minimum bend moment specification for this product.Based on the results of the bend moment test, the representative samples tested satisfactory.It was reported that the needle broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The needle should always be held in the middle where the diameter is greatest.Grasping the needle near the swaged end or the tip could cause bends, breaks, or damage the connection between the needle and suture.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21635919
• Report Number: 9612501-2025-00790
• Device Sequence Number: 15328180
• Product Code: GAM
• UDI-Device Identifier: 10884521045545
• UDI-Public: 10884521045545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: GLJ-50-M
• Device Catalogue Number: GLJ-50-M
• Device Lot Number: D4G2922Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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