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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an open reduction and internal fixation surgery of the tibia and perone, in order to reduce the fracture, the specialist needed to place two screws from cortical to cortical.When performing the passage with the evos small 2.0mm drill w/ao qc short and later when removing it from the bone it was evidenced that the drill bit came out incomplete.Later x-ray showed that the tip of the drill was still inside the bone, and it was impossible to remove.There was a non-significant delay and the procedure was finished using a smith & nephew back up.Patient current health status is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the definitive contributing clinical factors cannot be determined; however, the end-user technique could not be ruled out as a contributing factor to the retained fragment of the non-implantable instrument.The provided imaging appears to show the distal drill bit tip fragment/foreign body retained in the tibia just inferior and almost parallel and approximately one third the length of the long screw.The instrument appears to be missing the distal spiral cutting edge tip.The material composition is shown as stainless steel and the instrument is manufactured and intended as an externally communicating device which is not approved for long term internal tissue exposure; therefore, long term implantation data is not available.The patient impact included the retained non-implantable foreign body, use of a backup device to complete the procedure, and the reported 30 minute surgical delay.Although unlikely, possible micro-motion and/or migration of the foreign body fragment along with local irritation/discomfort cannot completely ruled out.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 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 instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices for single use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.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 specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip of the device broke off.The broken piece was not returned.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.The clinical/medical evaluation concluded that based on the limited information provided, definitive contributing clinical factors cannot be concluded; however, the end-user technique could not be ruled out as a contributing factor to the retained fragment of the non-implantable instrument.The patient impact included the retained non-implantable foreign body, use of a backup device to complete the procedure, and the reported 0-30-minute surgical delay.Although unlikely, possible micro-motion and/or migration of the foreign body fragment along with local irritation/discomfort cannot completely ruled out.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if it comes in contact with blood, tissue or bodily fluids.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS SMALL 2.0MM 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: 17367975
• Report Number: 1020279-2023-01481
• Device Sequence Number: 7404923
• Product Code: HWE
• UDI-Device Identifier: 00885556635759
• UDI-Public: 00885556635759
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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: 71175021
• Device Catalogue Number: 71175021
• Device Lot Number: 20KUQ0033A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/17/2023; 10/17/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/18/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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: Other
• Patient Sex: Female