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

Catalog Number UNKN02100107

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

Patient Problem Bone Fracture(s) (1870)

Event Date 06/01/2021

Event Type  Injury  

Event Description

It was reported that, on literature review ""clinic effect of tibiotalocalcaneal arthrodesis using the trigen hindfoot fusion intramedullary nail"", 1 patient who underwent primary implantation of a trigen hindfoot nail to treat hindfoot lesions experienced a stress fracture around the proximal locking hole after fusion. The fracture eventually healed after external plaster fixation. The patient's outcome is unknown. No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4). "clinic effect of tibiotalocalcaneal arthrodesis using the trigen hindfoot fusion intramedullary nail". Doi: 10. 3969/j. Issn. 1671-301x. 2021. 03. 015.

• 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: 14024172
• MDR Text Key: 288690697
• Report Number: 1020279-2022-01558
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKN02100107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/06/2022 Patient Sequence Number: 1