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

Catalog Number	7210914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a lumbar fusion internal fixation for lumbar spondylolisthesis with intraoperative muscle closure using ultrabraid sutures, and the patient was discharged clinically healed.However, on september 6, 2023, a wound ulcer formation was noted on the low back, and on september 13, a wound ulcer debridement and suturing was performed and the wound was closed.The patient was discharged well healed as of the date of the report, no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H10 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.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.Based on the information available, 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 found which would have definitively contributed to the event.The patient impact is the lower back wound ulceration formation, and additional surgery to debride/suture and close wound.Per case details, the patient was discharged well healed (¿as of the date of the report¿) without further reports of complications.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.

• Brand Name: ULTRABRAID #2 WHITE 38 LENGTH, SINGLE
• 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: 18326731
• Report Number: 1219602-2023-02444
• Device Sequence Number: 12610302
• Product Code: GAT
• UDI-Device Identifier: 03596010511942
• UDI-Public: 03596010511942
• 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
• Report Date (Section B): 01/05/2024

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 Catalogue Number: 7210914
• Device Lot Number: UNKNOWN
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male