MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRBRD#2 COBRAID 38 SNGL ARM PACK AS; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	7211081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Rupture (2208); Swelling/ Edema (4577)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a procedure to fix an ankle fracture with separation of tibiofibular syndesmosis using an ultrabraid suture, the patient's wound was ruptured, exuded, purulent, and swollen five days post-op.Debridement was performed and the suture was removed.Patient required a prolonged hospitalization as a result of the adverse event.Current status of the patient is recovered.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.It has been communicated that has recovered from the reported events.Should any additional clinical information be provided this complaint will be re-evaluated.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: ULTRBRD#2 COBRAID 38 SNGL ARM PACK AS
• 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: 15090732
• Report Number: 1219602-2022-01047
• Device Sequence Number: 20037222
• Product Code: GAT
• UDI-Device Identifier: 03596010547682
• UDI-Public: 03596010547682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: 7211081
• Device Catalogue Number: 7211081
• Device Lot Number: 74D2102105
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 07/24/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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; Hospitalization
• Patient Sex: Male