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

Model Number	72200886
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Event or Problem Description
It was reported that after a left side hip replacement on (b)(6) 2022; in which an ultrabraid suture was used to suture and repair the ligaments around the joint.The postoperative wound healed well.On (b)(6) 2023, the patient experienced redness and swelling of the incision, which persisted for a long time after incision and drainage; therefore the patient entered the hospital again for treatment on (b)(6) 2023.On (b)(6) 2023, the patient underwent incision debridement, exploration, and foreign body removal surgery.During the surgery, it was found that the fistula was related to the suture of the device.Patient outcome is unknown.
Additional Manufacturer Narrative
H2: updated section h6 (clinical code and impact code).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided 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 as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported redness and swelling of the incision and fistula, and a causal relationship between the ultrabraid suture and the reported clinical symptoms cannot be confirmed.The patient impact beyond the subsequent hospitalization and additional surgery could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 17050923
• Report Number: 1219602-2023-00833
• Device Sequence Number: 14316368
• Product Code: GAT
• UDI-Device Identifier: 03596010587657
• UDI-Public: 03596010587657
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2023

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: 72200886
• Device Catalogue Number: 72200886
• Device Lot Number: UNKNOWN
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 11/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Other; Required Intervention
• Patient Sex: Unknown