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

Model Number	71175022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the evos small 2.5mm drill w/ao qc long was broken and the surgeon decided to leave it inside.The procedure was completed, with a non-significant delay, using a s+n back-up device.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an open reduction in an internal fixation of tibial platu, an evos small 2.5mm drill w/ao qc long broke and the surgeon decided to leave it inside the patient.The procedure was completed, with a non-significant delay, using a s+n back-up device.Patient was not harmed beyond the problem reported.
Additional Manufacturer Narrative
B4, h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports a drill bit breakage of the evos 2.5mm long drill during an open reduction internal fixation tibia plateau.According to the report, the surgeon made the decision to leave the broken drill bit inside of the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Consequently, the clinical root cause of the reported drill bit breakage could not be determined.Per subsequent e-mail, no additional surgery is required.The evos 2.5mm long drills are comprised of 17.4 ph ss, they are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.Although we cannot make conclusions on the patient impact of the non-implantable foreign body, we cannot rule out the possibility of micro-motion and/or migration, local skin irritation and discomfort.Based on the information provided, the procedure was completed with a non-significant delay, using a s+n back-up device.According to the report, the patient was not harmed as consequence of this problem.Therefore, no further medical assessment can be rendered at this time.Should any additional relevant clinical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.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.We consider this investigation closed.

• Brand Name: EVOS SMALL 2.5MM DRILL W/AO QC LONG
• 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: 14072042
• Report Number: 1020279-2022-01749
• Device Sequence Number: 11424844
• Product Code: HWE
• UDI-Device Identifier: 00885556635766
• UDI-Public: 00885556635766
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 71175022
• Device Catalogue Number: 71175022
• Device Lot Number: 21JUQ0026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/07/2022
• Date Device Manufactured: 10/06/2021
• 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