MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTURE, #2 WHITE, ULTRABRAID, 38"; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	7211080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Date of Event	03/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the initial achilles tendon rupture surgery was performed on (b)(6) 2022, and on (b)(6) 2023 the patient self-noticed redness and swelling around the wound.The wound was admitted on (b)(6) 2023 and was found to be red, swollen, and pus-filled.The ultrabraid suture was removed on (b)(6) 2023 (b)(6).After that, a debridement procedure was performed for treatment.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H10: h2: additional information: d4: lot number and expiration date.H4.Corrected data: d4: catalog number and unique identifier (udi) #.
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.A review of device records and sterilization records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that there were no clinical factors identified which would have contributed to the reported event.The patient impact includes the additional surgical procedure for debridement and removal of the implant.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - clinical code).

• Brand Name: SUTURE, #2 WHITE, ULTRABRAID, 38"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18284369
• Report Number: 1219602-2023-02392
• Device Sequence Number: 6762061
• Product Code: GAT
• UDI-Device Identifier: 03596010547675
• UDI-Public: 03596010547675
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 7211080
• Device Lot Number: 74C2001076
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 04/09/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/26/2023; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2020
• 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: 34 YR
• Patient Sex: Male