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

Catalog Number	71175025
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7931236
• Report Number: 1020279-2018-01904
• Device Sequence Number: 13918143
• Product Code: JDS
• UDI-Device Identifier: 00885556635810
• UDI-Public: 00885556635810
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71175025
• Device Lot Number: 17HNX0010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention