MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.5MM DRILL W/AO QC SHORT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	71175023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a internal fixation surgery, the tip of an evos small 2.5mm drill w/ao qc short broke off inside patient.Surgeon decided to leave it in the bone.Surgery was resumed, after a non-significant delay, with a back-up device.The current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the tip of an evos small 2.5mm drill w/ao qc short broke off inside patient.According to the report, the surgeon decided to leave the broken tip of the evos small 2.5mm drill w/ao qc short inside the patient¿s bone.No clinically relevant information has been provided for inclusion in this investigation.The evos small 2.5mm drill w/ao qc short was manufactured and intended as an external communicating device and they are not approved for long-term internal tissue exposure and long-term implantation data is not available.Since the surgeon left the tip in the bone, migration is unlikely.Per subsequent e-mail, it was reported, the remaining drill bit thrown was thrown away.Based on the information provided, the surgeon resumed surgery with a backup device with a non-significant delay.The impact to the patient beyond that which has already been reported is unknown.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: EVOS SMALL 2.5MM DRILL W/AO QC SHORT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12135986
• Report Number: 1020279-2021-05833
• Device Sequence Number: 4304190
• Product Code: HWE
• UDI-Device Identifier: 00885556635773
• UDI-Public: 00885556635773
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 71175023
• Device Catalogue Number: 71175023
• Device Lot Number: 21175023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown