MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TAYLOR SPATIAL FRAME EXFIX DEV; PIN, FIXATION, THREADED

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/10/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on literature review ¿high tibial osteotomy in medial compartment osteoarthritis and varus deformity using the taylor spatial frame: early results" , a case of deep vein thrombosis was reported while using a taylor spatial frame external fixation device.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the data presented in the aged article did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse, injury, procedural/user error, surgical complication or patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN TAYLOR SPATIAL FRAME EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11256308
• MDR Text Key: 229576439
• Report Number: 1020279-2021-00791
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention