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	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, while performing an osteosynthesis, the tip of an evos small 2.5mm drill w/ao qc short broke.The broken piece was left inside the patient.Surgery was resumed, without any delay, with a backup device.It is unknown the current health status of the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and revealed that the tip of the device is broken off.The clinical/medical investigation concluded that, this case reports a tip breakage of an evos small 2.5mm drill w/ao qc short when drilling in the place where the screw was to be placed, and the broken drill tip was not recovered from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Consequently, the root cause of the reported drill tip breakage could not be determined.The evos small 2.5mm drill w/ao qc short are comprised of 17.4 ss, these devices 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.Since the drill tip was left in the patient¿s bone micro-motion/migration is unlikely, however, we cannot make conclusions on the impact of the non-implantable foreign body.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.According to the report, the surgery was resumed, without any delay, with a backup device.It was reported the current health status of the patient is unknown.Therefore, no further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, 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 potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.As the device can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.Based on this investigation, the need for corrective action is not indicated.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 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: 15592090
• Report Number: 1020279-2022-04413
• Device Sequence Number: 2072064
• Product Code: HWE
• UDI-Device Identifier: 00885556635773
• UDI-Public: 00885556635773
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 21AUQ0007
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male