MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88863015-61
Medical Device Problem Codes	Product Quality Problem (1506); Device Slipped (1584); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 88863015-61, 88863015-61 ticron* 0 blu 120cm v20x36 (lot#d3c0769y); 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 a laparoscopic hiatoplastic/fundoplication procedure, the knots of the twelve sutures could not easily slide onto the tissue, sometimes the knot/tie stopped before making contact with the tissue, and these strings remained in the patient.The pulled strings were not floating in the patients cavity.Additionally, the thread appeared unbraided, making it difficult to knot, and the strength of the knots was poor.It took a lot more time to suture.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the knots were difficult to tie, the knots slipping and suture appearance.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 18953288
• Report Number: 9612501-2024-00807
• Device Sequence Number: 17905049
• Product Code: GAT
• UDI-Device Identifier: 10884521059016
• UDI-Public: 10884521059016
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K930591
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Model Number: 88863015-61
• Device Catalogue Number: 88863015-61
• Device Lot Number: D3C0769Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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