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 Non-union Bone Fracture (2369)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

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", one patient suffered from a non-union after external fixation treatment with the taylor spatial frame system.The non-union occurred in a patient with an open talus fracture-dislocation secondary to a suicide attempt.The issue was treated with a hindfoot fusion nail and went on to successful union.No further information is available.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, one patient (sited from a retrospective cohort review) experienced non-union after treatment with the tsf external fixation for an unreconstructable open talus fracture-dislocation secondary to a suicide attempt.It was communicated that patient specific medical documentation would not be provided due to patient confidentiality; however, ¿it seems that complications were not related to the product itself¿.Article detailed that the issue was ¿treated later with hindfoot fusion nail(s) and went on to successful union¿.Graphs and images provided in the article have been interpreted within the text; therefore, no further analysis is required.Without the requested patient specific medical documentation, definitive clinical factors which could have contributed to the reported revisions could not be concluded.The patient impact beyond the reported non-union and subsequent hindfoot fusion procedure could not be determined, although the article noted the patient ¿went on to successful union¿.No further medical assessment can be rendered 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 injury, procedural/user error, surgical/post operative complications, healing issues, patient condition, surgical technique used and/or user/procedural variance.The contribution of the device to the reported event could not be corroborated.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.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 ; austin, TX 78735 ; 5123913905
• MDR Report Key: 15293088
• MDR Text Key: 298580819
• Report Number: 1020279-2022-03839
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• 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
• Date Manufacturer Received: 09/21/2022
• 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): Required Intervention; Hospitalization