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

Model Number	CL-914
Medical Device Problem Codes	Mechanical Problem (1384); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Fever (1858); Necrosis (1971); Pallor (2468)
Date of Event	08/29/2025
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.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 an open reduction and internal fixation of a right tibial fracture and right fibular fracture under general anesthesia, after the plate was implanted, 0 absorbable synthetic surgical suture was used for interrupted, layered closure of the subcutaneous tissue and deep fascia.On the second day after surgery, the patient began to experience recurrent fever, with a maximum temperature of 38.5°c, accompanied by pallor and liquid exudation of the skin around part of the incision.Subsequent skin necrosis was observed and later, suture knots were found to be expelled from the subcutaneous tissue during dressing changes.To resolve the issue, the patient was treated with anti-inflammatory therapy and enhanced wound care, with infrared irradiation of the incision to promote blood circulation.
Event or Problem Description
According to the reporter, during an open reduction and internal fixation of a right tibial fracture and right fibular fracture under general anesthesia, after the plate was implanted, 0 absorbable synthetic surgical suture was used for interrupted, layered closure of the subcutaneous tissue and deep fascia.On the second day after surgery, the patient began to experience recurrent fever, with a maximum temperature of 38.5°c, accompanied by pallor and liquid exudation of the skin around part of the incision.Subsequent skin necrosis was observed, and later, suture knots were found to be expelled from the subcutaneous tissue during dressing changes.To resolve the issue, the patient was treated with anti-inflammatory therapy and enhanced wound care, with infrared irradiation of the incision to promote blood circulation.
Additional Manufacturer Narrative
Additional information: a4, 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.

• 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: 23345647
• Report Number: 1219930-2025-04804
• Device Sequence Number: 9452311
• Product Code: GAM
• UDI-Device Identifier: 10884521043329
• UDI-Public: (01)10884521043329(17)281130(10)A3M1830Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/24/2025

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: CL-914
• Device Catalogue Number: CL-914
• Device Lot Number: A3M1830Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Date Device Manufactured: 12/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 70 KG