MAUDE Adverse Event Report: COVIDIEN SURGICAL POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	GL-222
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hemorrhoid procedure involving the mucous membrane, the tip of the suture needle broke while suturing, and the broken needle tip fell into the patient's cavity.The needle was located without the need for imaging and was retrieved from the patient cavity.It occurred on three sutures.An additional new suture was used without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant products: gl-222, gl-222 polysorb* 3-0 vio 75cm v30 x36 (lot# a4l1784y) gl-222, gl-222 polysorb* 3-0 vio 75cm v30 x36 (lot# a4l1784y) 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
Additional information: d3 (mfr name and street 1), d4 (udi), d9, g3, h3, h6.H3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection of the opened samples noted one suture and one needle.The needle was received intact with toolmarks near the tip of the needle.It was reported that the needle broke.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: damaged needle.The product analysis noted evidence that the device was not used as intended.Always hold the needle 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.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: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22391259
• Report Number: 1219930-2025-02819
• Device Sequence Number: 9180273
• Product Code: GAM
• UDI-Device Identifier: 10884521045132
• UDI-Public: (01)10884521045132(17)291031(10)A4L1784Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/19/2025

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: GL-222
• Device Catalogue Number: GL-222
• Device Lot Number: A4L1784Y
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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 Age: 54 YR
• Patient Sex: Female