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 Problem Bone Fracture(s) (1870)

Event Date 09/28/2018

Event Type  Injury  

Event Description

On the literature article named "combined intramedullary nail coated with antibiotic-containing cement and ring fixation for limb salvage in the severely deformed, infected, neuroarthropathic ankle", it was reported that one patient suffered from a proximal tibial fracture.It is unknown how the adverse event was treated.The outcome of the patient is unknown.

Manufacturer Narrative

G3, h2,h3 and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the patient suffered from a proximal tibia fracture; the treatment is unknown.Per subsequent e-mail, no further clinical information will be provided.Therefore, 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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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: 12096606
• MDR Text Key: 259359538
• Report Number: 1020279-2021-05564
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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: UNKN02300100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN TRIGEN HINDFOOT FUSION NAIL IMPL/ UNKNOWN
• Patient Outcome(s): Hospitalization; Other; Required Intervention