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

Catalog Number UNKN02300100

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369)

Event Date 07/18/2021

Event Type  Injury  

Event Description

It was reported that, on the literature review "strategies and outcomes in severe open tibial shaft fractures at a major trauma center: a large retrospective case-series", a (b)(6) female patient who underwent primary implantation of a taylor spatial frame fixator to treat a severe open tibial shaft fracture experienced nonunion which eventually progressed to a bony union outcome after a revision procedure was performed with 5cm of devitalized bone excision involved.The postoperative periods during which the nonunion outcome was diagnosed and the bony union was achieved are unknown.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Patel, k; logan, k & krkovic, m.(2021).Strategies and outcomes in severe open tibial shaft fractures at a major trauma center: a large retrospective case-series.World journal of orthopedics.Vol 12, art 7, pag:495-504.Doi: 10.5312/wjo.V12.I7.495.(b)(4).

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, this case reports, in a literature review, a 19-year old female patient who underwent primary implantation of a taylor spatial frame fixator to treat a severe open tibial shaft fracture experienced nonunion which eventually progressed to a bony union outcome after a revision procedure was performed with 5cm of devitalized bone excision involved.The postoperative periods during which the nonunion outcome was diagnosed, and the bony union was achieved are unknown.However, the nonunion of the bone would not be a mal-performance of the product.No further information is available.Without clinical and patient specific information, a thorough medical investigation cannot be performed.The clinical root cause and the impact to the patient beyond that which was documented in the article cannot be confirmed nor concluded.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 excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues, patient condition, and/or overuse.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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15287141
• MDR Text Key: 298558954
• Report Number: 1020279-2022-03813
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02300100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• 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
• Patient Age: 19 YR
• Patient Sex: Female