MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T8 LINEAR DRIVER SHAFT W/ AO QC; SCREWDRIVER

Model Number 71174986

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/27/2020

Event Type  Injury  

Event Description

It was reported that during the procedure, that the t8 linear driver shaft was broke (inside the patient, but all pieces were recovered) while inserting the 2.7mm evos locking screw into the plate.The procedure was completed without delay.The procedure was finished with a standard t8 screwdriver.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.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.We consider this investigation closed.G1.

• Brand Name: T8 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: 10174386
• MDR Text Key: 195748921
• Report Number: 1020279-2020-02603
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556500590
• UDI-Public: 00885556500590
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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
• Device Model Number: 71174986
• Device Catalogue Number: 71174986
• Device Lot Number: 17HUP0020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 72440108N
• Patient Outcome(s): Hospitalization; Required Intervention