MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT; SCREWDRIVER

Model Number 71175073

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

It was reported that the hex driver is stripped and needs to be replaced.Fault in device was noticed during procedure, while instruments were outside the patient.Procedure was completed using a s+n backup device.No surgical delay of injury to the patient was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment was returned for evaluation: a visual inspection of the returned device confirmed the stated failure mode.The device is stripped rendering it inoperable.A review of complaint history did reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10788254
• MDR Text Key: 214724132
• Report Number: 1020279-2020-06163
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556636053
• UDI-Public: 00885556636053
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71175073
• Device Catalogue Number: 71175073
• Device Lot Number: 17HUP0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1