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

Model Number	7210914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an open exploration, reduction and internal fixation for the avulsion fracture of the left lateral condyle of the humerus in which a kirschner wire and ultrabraid suture were used to help fix the fracture end, the ultrabraid suture was exposed, and the patient was treated in the outpatient department.The symptoms did not improve after repeated treatment and the patient underwent a debridement and exploration of the left elbow wound and removal of foreign bodies.During the operation, it was found that the inflammatory granuloma wrapped the original internal fixation super strong suture, and the inflammatory tissue around the suture proliferated.No additional complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was 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.As of the date of this medical investigation, the requested clinical documentation including the operative report or imaging has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported cannot be determined.However, it was communicated, ¿the operation site of the patient healed after operation,¿ and no additional complications were reported.No patient injury has been reported.Therefore, no further clinical/medical assessment is warranted.There was no relationship found between the device and the reported event.The complaint was not confirmed.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: 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: 15698685
• Report Number: 1219602-2022-01639
• Device Sequence Number: 20392942
• 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): 11/14/2022

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 Expiration Date: 09/19/2025
• Device Model Number: 7210914
• Device Catalogue Number: 7210914
• Device Lot Number: 74H2001798
• 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: 10/08/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/14/2022
• Date Device Manufactured: 09/19/2020
• 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: Other
• Patient Sex: Unknown