MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR; SCREWDRIVER

Model Number 71175072

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 10/20/2020

Event Type  Injury  

Event Description

It was reported that during surgery (orif ankle), inside the patient, the tip of the hex driver fell off.No delay reported.No patient injuries reported.A s&n backup was available.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned evos fixed handle confirms the tip of the device is broken off.The broken piece was not returned with the device.This device shows significant signs of wear/ usage.A medical investigation was conducted and this case reports the tip of the hex driver fell off while using it to place/tighten perc guide.Per email communication, the tip remained in perc guide, and nothing was left inside the patient.There was no patient injury or delay, and the procedure was completed using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints 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.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10826503
• MDR Text Key: 215873666
• Report Number: 1020279-2020-06404
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556636046
• UDI-Public: 00885556636046
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71175072
• Device Catalogue Number: 71175072
• Device Lot Number: 17HUP0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention