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

Catalog Number UNKNOWN

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

Patient Problem Ambulation Difficulties (2544)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Ordas-bayon, a., logan, k., garg, p., peat, f., & krkovic, m.(2021).Ankle arthrodesis using the taylor spatial frame for the treatment of infection, extruded talus and complex pilon fractures.Injury, 52(4), 1028-1037.Doi: doi.Org/10.1016/j.Injury.2021.02.003.

Event Description

It was reported that on literature review "ankle arthrodesis using the taylor spatial frame for the treatment of infection, extruded talus and complex pilon fractures", 2 patients were not able to fully weight bear after external fixation treatment with the taylor spatial frame system.Additionally, 3 patients were able to fully weight bear, but required crutches.The ambulatory difficulties were permanent.No further information is available.

Manufacturer Narrative

Section h10: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, this case reports, in a literature review, 2 patients were not able to fully weight bear after external fixation treatment with the taylor spatial frame system.Additionally, 3 patients were able to fully weight bear, but required crutches.The ambulatory difficulties were permanent.No further information is available.Without clinical documentation and patient specific information, a thorough medical investigation cannot be performed.The patients¿ outcomes beyond the permanent ambulatory difficulties, which were stated in the article cannot be confirmed.Further, it cannot be concluded that the issues were caused by a mal-performance of the product.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes that could contribute to the reported events have been identified as patient reaction, post-operative healing issue and/or patients condition.The contribution of the devices to the reported events could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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.Internal complaint reference number: (b)(4).

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15415440
• MDR Text Key: 299830676
• Report Number: 1020279-2022-04090
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other