MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.7MM OVERDRILL W/AO QC SHORT; NAIL, FIXATION, BONE

Catalog Number 71175025

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 08/31/2018

Event Type  Injury  

Event Description

Drill got stuck in drill guide, on removal, this hit the scrub nurse on the hand and pulled the medical fragment from the bone of the patient.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection found that the drill bit has become lodged in a drill guide.It is possible that side loading was applied to the bit during operation, causing it to lodge in the guide.This device exhibits signs of significant wear/usage.This device was manufactured in 2017.A clinical evaluation was conducted and based on the limited clinical details provided and the product evaluation, currently unable to rule out side loading on the drill bit as a possible contributing factor the reported event.The patient impact beyond the fragment of unknown size and location fixed via lag screw placement cannot be concluded.No further medical assessment can be rendered 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 any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 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 SMALL 2.7MM OVERDRILL W/AO QC SHORT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7931236
• MDR Text Key: 122533880
• Report Number: 1020279-2018-01904
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556635810
• UDI-Public: 00885556635810
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71175025
• Device Lot Number: 17HNX0010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention