MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION NAIL IMPL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problem Impaired Healing (2378)

Event Date 03/23/2011

Event Type  Injury  

Event Description

It was reported that, after a primary trauma surgery had been performed on the patient's left hindfoot on (b)(6) 2010, in which a hfn 10mm x16cm left nail was implanted with four screws placed across the proximal tibial region (x2), distal talar (x1) and distal posteroanterior region (x1) to treat a post-traumatic left ankle and subtalar arthrosis, the patient required an additional surgery on (b)(6) 2011 to remove one of the screws from the left heel due to the formation of a prominent eschar.There is no confirmation on whether another screw was implanted in exchange.A complete fusion was achieved and confirmed by x-ray assessment 12 weeks postoperatively, although it is unknown if the reported time frame is related to the primary surgery or to the additional intervention performed.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.

Manufacturer Narrative

Reference number: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the post-market clinical follow up activity (pmcf) was anonymous.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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 healing issues, injury, infection and/or patient condition.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.

• Brand Name: UNKN TRIGEN HINDFOOT FUSION NAIL IMPL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12788433
• MDR Text Key: 280596705
• Report Number: 1020279-2021-08000
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 86 KG