SMITH & NEPHEW, INC. ULTRABUTTON ADJUSTABLE FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72290003 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 10/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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(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.
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Manufacturer Narrative
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H2: additional information ¿b5¿.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.
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Event Description
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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 being recovered and its now waiting another monitoring visit on (b)(6) 2021.
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Manufacturer Narrative
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G1: updated.Report was inadvertently submitted under manufacturer number 3006524618 but the correct manufacturer number is (b)(4).
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Manufacturer Narrative
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D3 corrected: manufacturing name, city and address.
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