MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER; SCREWDRIVER

Model Number 71175077

Device Problem Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2020

Event Type  malfunction  

Event Description

It was reported that before surgery while getting ready for the case the screw driver was found to be stripped.It is unknown if there was a delay o how the procedure was finished.No injuries reported at this time.

Manufacturer Narrative

The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the tip is damaged on the evos small t8 fixed handle linear driver, which would cause the device not to function as intended.The device shows significant signs of wear/usage.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 products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.

• Brand Name: EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10380674
• MDR Text Key: 202073685
• Report Number: 1020279-2020-03783
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556636077
• UDI-Public: 00885556636077
• 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
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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: 71175077
• Device Catalogue Number: 71175077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1