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

Model Number 71175072

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2020

Event Type  Injury  

Event Description

It was reported that the tip of driver sheared off.Event occurred during use, with instruments inside the patient.Procedure was completed using a sn backup device.No delay or 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

H6: 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 instrument was manufactured in 2018.This device shows significant signs of wear/ usage.A medical investigation was conducted and confirms based on the limited information provided the root cause of the reported tip breakage cannot be determined.However, based on the results of the product evaluation, age related wear could not be rule out as a contributing factor.The tip is made of 17.4 stainless steel, which is not implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.Per report, the procedure completed with a backup device, with no delay or injury.Therefore, no further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 the risk management file revealed this failure mode was previously identified.This device is a reusable instruments 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 complaint will be reopened.No further investigation 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 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: 10668075
• MDR Text Key: 210986530
• Report Number: 1020279-2020-05352
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556636046
• UDI-Public: 00885556636046
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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: 18GUP0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention