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

Model Number	71175077
Medical Device Problem Codes	Defective Device (2588); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle procedure the evos small t8 fixed handle linear driver got stripped and does not engage the screw head properly.This happened during use inside the patient.Surgeon had backup s&n drivers to use in its place.No delay reported.No injuries or other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional 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 tip of the driver is stripped and will not perform its designed function.The device was manufactured in 2017 and 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 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 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.

• Brand Name: EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10404748
• Report Number: 1020279-2020-03908
• Device Sequence Number: 2757797
• Product Code: HXX
• UDI-Device Identifier: 00885556636077
• UDI-Public: 00885556636077
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71175077
• Device Catalogue Number: 71175077
• Device Lot Number: 17MUP0004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention