MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 250MM BAR; PIN, FIXATION, THREADED

Model Number 71062250

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Event Description

It was reported that, during an external fixation, two (2) jet-x 250mm bar's carbon fiber had splintered, and tore the glove of one of the surgeon making the adjustment.It is mentioned that this splinter could have stabbed anyone needed to access this part of the construct, including the patient, resident or attending surgeon, but no one was harmed as consequence of this problem.Fixation was resumed, after a non-significant delay, with a back-up device.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the splintered, but the indention in the bar appears to be from use.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.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: 250MM BAR
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12058157
• MDR Text Key: 258128605
• Report Number: 1020279-2021-05419
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010486691
• UDI-Public: 03596010486691
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71062250
• Device Catalogue Number: 71062250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1