MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XTENDOBUTTON ROUND MD17 DIA 7.5 PEG; RETENTION DEVICE, SUTURE

Model Number	71935602
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an alc with xtendobutton, the patient developed deep vein thrombosis.The condition was treated with medication (xarelto 15 mg and apixaban) twice per day via oral.The patient recovered successfully.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.A review of device 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.Based on the limited information provided we are unable to conclude factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.

• Brand Name: XTENDOBUTTON ROUND MD17 DIA 7.5 PEG
• Common Device Name: RETENTION DEVICE, SUTURE
• 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: 10544865
• Report Number: 1219602-2020-01413
• Device Sequence Number: 11067092
• Product Code: KGS
• UDI-Device Identifier: 00885556702703
• UDI-Public: 00885556702703
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71935602
• Device Catalogue Number: 71935602
• Device Lot Number: 19BCT0016K
• 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: 08/25/2020
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 03/13/2024
• Date Device Manufactured: 06/06/2019
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 51 KG