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 06/19/2020

Event Type  Injury  

Event Description

It was reported that during an ankle open reduction internal fixation procedure, when putting down a 3.5 screw, the tip of the screwdriver snapped off.All pieces were retrieved.Surgery was finished with an s+n backup device.

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 instrument was manufactured in 2017.This device shows significant signs of wear/ usage.A medical investigation was conducted and per the complaint details, during the ankle orif, the screwdriver tip snapped; however, all pieces were retrieved and the procedure was successfully completed with a backup device within a 0-30 minute surgical procedure.Reportedly, no additional interventions or x-rays were required.The patient impact beyond the reported event and the modified surgical procedure using a backup device could not be determined, although no patient injury was reported.No further medical assessment is warranted at this time.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: 10270203
• MDR Text Key: 198693093
• Report Number: 1020279-2020-03183
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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: 17HUP0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention