MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T6 LINEAR DRIVER SHAFT W/ AO QC; SCREWDRIVER

Model Number 71174984

Device Problems Physical Resistance/Sticking (4012); Thickening of Material (4056)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads on the device was found to be stripped, rendering the device inoperable.The device shows signs of extensive use.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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.

Event Description

It was reported that during trauma procedure, the holding sleeve of a t6 linear driver shaft w/ ao qc got stuck.There was a reported delay of fewer than 30 minutes.The procedure was completed with a smith and nephew back-up device.No patient injury or other complications were reported.After visual inspection of the reported device it was found that the threads on the device was found to be stripped, rendering the device inoperable.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned, and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads on the device was found to be stripped, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: T6 LINEAR DRIVER SHAFT W/ AO QC
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11962674
• MDR Text Key: 255045365
• Report Number: 1020279-2021-05056
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556500491
• UDI-Public: 00885556500491
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71174984
• Device Catalogue Number: 71174984
• Device Lot Number: 19JUP0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1