MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN ANTEGR TIB/RETROGR FEM NAIL TIBIAL; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

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

Patient Problem Discomfort (2330)

Event Date 07/12/2020

Event Type  Injury  

Event Description

It was reported that on literature review "factors associated with subsequent surgical procedures after intramedullary nailing for tibial shaft fractures", 9 patients underwent an additional surgery to remove a tibial nail due to irritation or pain after an internal fixation surgery with the intertan system, to treat a tibial shaft fracture.The outcome of the patients is unknown.There is no information within the study to determine whether these adverse events occurred in (b)(6).No further information is available.

Manufacturer Narrative

The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that patient specific supporting documentation has not been provided as of the date of this medical investigation.The clinical root cause of the reported irritation or pain with subsequent removal of symptomatic tibial nail cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.The contribution of the devices 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 devices 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 TRIGEN ANTEGR TIB/RETROGR FEM NAIL TIBIAL
• Type of Device: NAIL, FIXATION, BONE
• 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
• MDR Report Key: 14281181
• MDR Text Key: 290677944
• Report Number: 1020279-2022-02098
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization