MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW; NAIL, FIXATION, BONE

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)

Event Date 06/05/2020

Event Type  Injury  

Event Description

It was reported that the patient had a subtrochanteric femur fracture and underwent a right femur intramedullary nailing on (b)(6) 2017.He subsequently developed a nonunion with hardware failure.The patient broke through the hole of the lag screw proximally at that time and underwent a revision surgery on (b)(6) 2018 (it is unknown if it was a s+n device).He was implanted an intertan nail.However, after a few years, the patient was complaining of pain due to a broken hardware of intramedullary nail proximally and a broken distal interlocking screw distally.The patient underwent another revision and was implanted with competitor's devices.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, although the office report provided by surgeon reported, the patient was complaining of pain, two years and three months post revision.The x-ray report indicated there was breakage of the im nail proximally and a broken distal interlocking screw distally.However, without the x-ray images, or other relevant medical information we are unable to confirm the reported adverse event.Per report, the surgeon plans to schedule the patient for an operative removal of the nail and a replacement of the im nail.Therefore, no further clinical/medical assessment is warranted at this time.Should additional medical information be provided, this complaint will be re-assessed.At this time, we have no reason to suspect that the products 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 overuse or excessive pressure on the joint, injury, infection and/or patient condition.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10264653
• MDR Text Key: 198537027
• Report Number: 1020279-2020-03143
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention