MAUDE Adverse Event Report: UNKN TRAUMA & EXTREMITIES DEV; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNKN02000000

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after an internal fixation surgery (date unknown) had been performed to treat a femoral shaft fracture, the proximal interlocking screw (unknown trauma & extremities device) of a trigen trochanteric antegrade nail lime 13mm x 44cm 130 degree left (concomitant) broke and a revision surgery was performed on (b)(6) 2021 to remove the nail and the screws, but some of the pieces of the proximal interlocking screws remained inside the patient.Current health status of the patient is unknown.

Manufacturer Narrative

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 attached medwatch form was reviewed, and it supports the complaint.However, smith and nephew has not received the device/adequate clinical documentation to fully evaluate the complaint.Based on the information provided, the trigen trochanteric antegrade nail lime 13mm x 44cm 130 degree left (concomitant) broke.It was reported, a revision was performed to remove the nail and the screws and some of the pieces of the proximal interlocking screws remained inside the patient.The retained pieces of the proximal interlocking screws are implantable, so biocompatibility is not an issue.However, we cannot rule the possibility of local tissue irritation, micro-motion and/or migration of the retained pieces.Since it was reported the patient¿s outcome is unknown.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant patient information be provided, this complaint would be re-assessed.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 TRAUMA & EXTREMITIES DEV
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• MDR Report Key: 12529901
• MDR Text Key: 273314431
• Report Number: 1020279-2021-07146
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• 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; Other; Required Intervention