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

Model Number	GL-34-MG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during an open gastrointestinal surgery, on intestinal anastomosis, the two needles broke and fell into the cavity of the patient.A c-shape arm was used to search for the broken needle, which extended the surgery time by two hours.Also, an x-ray was performed on (b)(6) 2024 to locate the component.The surgeon used another set of needles from another manufacturer to complete the case.
Additional Manufacturer Narrative
D10 concomitant product: gl-34-mg, gl-34-mg polysorb* 4-0 vio 5x45cm cv25dt, (lot #d3a1869y) 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: 19127628
• Report Number: 9612501-2024-00989
• Device Sequence Number: 7629252
• Product Code: GAM
• UDI-Device Identifier: 10884521045316
• UDI-Public: 10884521045316
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 04/17/2024

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: GL-34-MG
• Device Catalogue Number: GL-34-MG
• Device Lot Number: D3A1869Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/17/2024
• Date Device Manufactured: 01/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male