MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	SL-693
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Impaired Healing (2378); Skin Inflammation/ Irritation (4545)
Date of Event	10/09/2024
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, post operative a right tibia and fibula fracture open reduction and internal fixation (removal of internal fixation device) on the fourth day after the initial procedure, the patient's incision was found to have redness and swelling of the skin and poor healing.The suture was then removed.After the synthetic absorbable surgical sutures were removed, cefuroxime injection 1.5g twice a day and daily cleaning and dressing were continued.Subsequent rounds revealed that the patient's adverse reaction symptoms tended to disappear and the wound was gradually healing, but she still needed to extend hospitalization for observation.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20682823
• Report Number: 1219930-2024-05383
• Device Sequence Number: 7187611
• Product Code: GAM
• UDI-Device Identifier: 10884521049246
• UDI-Public: 10884521049246
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: SL-693
• Device Catalogue Number: SL-693
• Device Lot Number: A3E0634FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/14/2024
• Date Device Manufactured: 05/23/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female