MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.0MM DRILL W/AO QC SHORT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 71175021

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 08/14/2020

Event Type  Injury  

Event Description

It was reported that during a fixing of the medial mallaleous on a patient the drill broke off in the patient bone, just below where the flutes start.Dr was drilling into the tibia with the 2.0 bit.Left the drill in patient.Unknown how the procedure was finished and the outcome of the patient.

Manufacturer Narrative

G4, h2, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports the breakage evos drill, broken piece was not retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.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 risk management file revealed this failure mode was previously identified.Damage from misuse or rough handling are likely probable causes of the reported event.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.H6: clinical, impact, medical device problem and component code updated.

• Brand Name: EVOS SMALL 2.0MM DRILL W/AO QC SHORT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10505717
• MDR Text Key: 206086005
• Report Number: 1020279-2020-04476
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00885556635759
• UDI-Public: 00885556635759
• 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: 04/19/2021

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: 71175021
• Device Catalogue Number: 71175021
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention