MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number	SP-684
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	01/02/2025
Type of Reportable Event	Serious 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.
Event or Problem Description
According to the reporter during a skin closure procedure, the needle tip broke off from one of the six sutures used.It was noted that the broken tip was searched on the sterile field, and a magnet roller was used outside the surgical field.An intra-operative x-ray was performed and no abnormality detected.
Additional Manufacturer Narrative
Additional information: b3, d9, e1 (first name, last name), e2, e3, e4 (email), g3.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: b3, b5, e1, g3.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 subtotal gastrectomy, during skin closure, the needle tip broke off from one of the six sutures used.It was noted that the broken tip was searched on the sterile field, and a magnet roller was used outside the surgical field.An intraoperative x-ray was performed, and no abnormality was detected.A new suture was used to resolve the issue.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one suture and one needle.The needle was received broken at the tip.The needle was also bent at 1/3 of it's length from the needle swage.Upon microscopic inspection, instrument marks were observed near the break site and bend site.It was reported that the needle was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition: of bent needle that has no relationship to the reported condition.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.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: SURGIPRO
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• 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: 21265067
• Report Number: 9612501-2025-00255
• Device Sequence Number: 9538634
• Product Code: GAW
• UDI-Device Identifier: 10884521037489
• UDI-Public: 10884521037489
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954808
• 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,Followup
• Report Date (Section B): 04/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SP-684
• Device Catalogue Number: SP-684
• Device Lot Number: D2M0401FY
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 02/09/2025; 02/17/2025; 04/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/18/2025; 02/21/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown