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

Model Number	71935602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
(b)(6).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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
Study id: xtendobutton, clinical study: pmcf.2018.12, subject id: 12.006, ae#01: dvt.It was reported that after a acl surgery performed on 2/10/2019 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 10/10/2019.Then on 18/10/2019 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 13/11/2019 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 being recovered and its now waiting another monitoring visit on 27-28 of april 2021.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 isolated event.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.

• 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: 11617206
• Report Number: 1219602-2021-00772
• Device Sequence Number: 12974363
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2021

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 Model Number: 71935602
• Device Catalogue Number: 71935602
• Device Lot Number: 18MCT0022C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 11/16/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/04/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY, ANTICOAGULATION THERAPY. APIXABAN/ASPIRIN; THERAPY, ANTICOAGULATION THERAPY. APIXABAN/ASPIRIN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female