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

Model Number 71175073

Device Problems Difficult to Insert (1316); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  Injury  

Event Description

It was reported that during treatment the evos sm 2.5mm tapered hex dr shaft-short was being used and the tip of the device was slipping on the head of the multiple screws.There was no delay and no patient harmed.There was another sn product (evos sm 2.5mm tapered hex dr shaft-long) available to use.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 hex on the device is damaged and nicked which would make it difficult for the mating device to adhere to the device.This renders the device inoperative.The device shows signs of extensive use.Based on the information provide, there were no reported delays and a backup smith and nephew device was available to complete the procedure.Since there was no patient harm reported, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint will be re-assessed.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.A review of the risk management file revealed this failure mode was previously identified.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 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: 10775578
• MDR Text Key: 214293403
• Report Number: 1020279-2020-06054
• 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: 06/17/2021

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: 71175073
• Device Catalogue Number: 71175073
• Device Lot Number: 19HUP0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 06/12/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention