MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRABUTTON ADJUSTABLE FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

Study id: (b)(6).Clinical study: (b)(4).Subject id: (b)(6), ae#01: dvt.It was reported that after acl surgery with xtendobutton round md17 dia 7.5 peg and ultrabutton adjustable fixation device, the patient developed deep vein thrombosis.The condition was treated with medication(apixaban and aspirin), therapy and rest.The patient recovered successfully.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed the patient recovered from the reported injuries successfully and there is no longer an apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A relationship, if any, between the subject device and the reported event 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.

Event Description

Study id: (b)(6).Clinical study: (b)(6).Subject id: (b)(6).Ae#01: dvt.It was reported that after a acl surgery performed on (b)(6) 2019 with xtendobutton round md17 dia 7.5 peg and ultrabutton adjustable fixation device, the patient developed thrombus in one of the posterior tibial veins from 10 to 5cm below the knee crease, both peroneal veins from 20 to 10cm below the knee crease, and soleal vein from 22 to 6 cm below the knee crease and phasic flow was seen in the popliteal vein and above identified on (b)(6) 2019.Then on (b)(6) 2019 there was an improvement in the venous thrombosis of the soleal and posterior tibial veins, but the thrombus still persisted in the soleal vein.Then on (b)(6) 2019 there was noticed a short segment thrombus in one of 2 posterior tibial veins but this was a mild improvement of the calf dvt, there was no deterioration or proximal propagation.The condition was treated with medication(apixaban and aspirin), therapy and rest.The patient has been recovered and is now waiting for another monitoring visit on 27-28 of april 2021.

Manufacturer Narrative

B5, g1: updated.Report was inadvertently submitted under manufacturer number 3006524618, but the correct manufacturer number is 1219602.

Manufacturer Narrative

D3 corrected: manufacturing name, city and address.

• Brand Name: ULTRABUTTON ADJUSTABLE FIXATION DEVICE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 11617204
• MDR Text Key: 243908932
• Report Number: 3006524618-2021-00421
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556613825
• UDI-Public: 00885556613825
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 72290003
• Device Catalogue Number: 72290003
• Device Lot Number: 2031691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THERAPY, ANTICOAGULATION THERAPY. APIXABAN/ASPIRIN.; THERAPY, ANTICOAGULATION THERAPY. APIXABAN/ASPIRIN
• Patient Outcome(s): Other
• Patient Sex: Female